| FDA Action Update, March 2026: Lift on CRL, Expanded Approvals, and Priority Review |
pharmacytimes.com |
2 |
Apr 02, 2026 |
www.pharmacytimes.com |
| FDA Approves First New Molecular Entity Under National Priority Voucher Program |
fda.gov |
1 |
Apr 01, 2026 |
www.fda.gov |
| New FDA Drug Approvals for 2026 - Drugs.com |
drugs.com |
1 |
Apr 01, 2026 |
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| 6 FDA Decisions To Watch in Q2 2026 - BioSpace |
biospace.com |
1 |
Mar 30, 2026 |
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| FDA accepts NDA for iberdomide in relapsed/refractory myeloma - SOHO Insider |
soho.com |
1 |
Mar 30, 2026 |
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| FDA Grants Breakthrough Therapy Designation to Plixorafenib for BRAF V600E Glioma | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways |
targetedonc.com |
1 |
Apr 03, 2026 |
www.targetedonc.com |
| Egetis Announces FDA Acceptance and Priority Review of NDA for Emcitate(R) (tiratricol) for MCT8 Deficiency - BioSpace |
biospace.com |
1 |
Mar 30, 2026 |
www.biospace.com |
| Speeding Up Approvals, Getting More Drugs OTC Among FDA's Top Priorities |
medpagetoday.com |
1 |
Apr 01, 2026 |
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| BridgeBio Submits NDA for BBP-418 in LGMD2I/R9, Potentially the First Approved Therapy for Any Form of Limb-Girdle Muscular Dystrophy | NeurologyLive |
neurologylive.com |
1 |
Mar 31, 2026 |
www.neurologylive.com |
| Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in Gastrointestinal Stromal Tumors (GIST) |
globenewswire.com |
1 |
Apr 01, 2026 |
www.globenewswire.com |
| FDA, after turbulent year, leaves drugmakers guessing on its direction - BioPharma Dive |
biopharmadive.com |
1 |
Apr 01, 2026 |
www.biopharmadive.com |
| Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs - Stock Titan |
stocktitan.com |
1 |
Mar 30, 2026 |
stocktitan.com |
| Q2 2026 Preview: 6 FDA Decisions to Watch | HCPLive |
hcplive.com |
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Apr 03, 2026 |
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| [PDF] New Drug Therapy Approvals 2025 | FDA |
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www.prnewswire.com |
| Regulatory News & FDA Approvals - Precision Medicine Online |
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| Oncology Drugs Granted FDA Designations in September 2025 |
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— |
www.oncologynewsc... |
| FORE Biotherapeutics Receives Breakthrough Therapy Designation for Plixorafenib |
businesswire.com |
1 |
Apr 01, 2026 |
fore.bio |
| FDA Action Update, March 2026: Lift on CRL, Expanded Approvals, and Priority Review |
neurologylive.com |
4 |
Apr 02, 2026 |
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| New FDA Drug Approvals for 2026 - Drugs.com |
drugs.com |
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Apr 01, 2026 |
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| Oncology Drugs Fast-Tracked and Prioritized by the FDA in March 2026 |
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Apr 03, 2026 |
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| Speeding Up Approvals, Getting More Drugs OTC Among FDA's Top Priorities |
medpagetoday.com |
1 |
Apr 01, 2026 |
www.medpagetoday.com |
| Off-the-Shelf CAR T-Cell Therapy Granted Breakthrough Therapy Designation for Aggressive T-Cell Cancers |
ajmc.com |
1 |
Mar 31, 2026 |
vertexaisearch.cl... |
| FDA Grants Priority Review to Lirafugratinib for FGFR2+ Pretreated Cholangiocarcinoma |
targetedoncology.com |
1 |
Mar 30, 2026 |
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Apr 01, 2026 |
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| Egetis Announces FDA Acceptance and Priority Review of NDA for Emcitate(R) (tiratricol) for MCT8 Deficiency |
biospace.com |
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Mar 30, 2026 |
vertexaisearch.cl... |
| Praxis Precision Medicines Announces FDA Acceptance and Priority Review of New Drug Application for Relutrigine in Patients with SCN2A and SCN8A DEEs |
stocktitan.com |
1 |
Mar 30, 2026 |
www.stocktitan.net |
| Upcoming FDA Approvals: New Drugs and Therapies That May Be Approved in 2026 - GoodRx |
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Apr 13, 2026 |
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| Novel Drug Approvals for 2025 | FDA |
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www.fda.gov |
| FDA Grants Breakthrough Therapy Designation to Investigational ... |
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finance.yahoo.com |
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trial.medpath.com |
| 2025 FDA approvals - Nature |
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1 |
— |
www.nature.com |
| FDA Grants Breakthrough Therapy Designation to ETX101 for DS |
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— |
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| Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation ... |
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— |
www.merck.com |
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— |
trial.medpath.com |
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ir.revmed.com |
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— |
ir.revmed.com |
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Apr 20, 2026 |
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| NRx Pharmaceuticals (Nasdaq:NRXP) Welcomes Presidential Initiative to Accelerate Approval of Psychedelic Medications to Treat Depression, PTSD, and Suicidality - Stock Titan |
vertexaisearch.cloud.google.com |
3 |
Apr 20, 2026 |
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| Breaking: FDA Awards Priority Review Vouchers to Otsuka, Compass, and Usona |
vertexaisearch.cloud.google.com |
3 |
Apr 24, 2026 |
psychedelicalpha.com |
| Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher | Morningstar |
vertexaisearch.cloud.google.com |
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Apr 24, 2026 |
www.morningstar.com |
| President Trump Signs Executive Order to Accelerate Psychedelic Research and Access |
vertexaisearch.cloud.google.com |
1 |
Apr 18, 2026 |
psychedelicalpha.com |
| Regulatory tracker: FDA delays decision on Sanofi's subcutaneous Sarclisa | Fierce Pharma |
fiercepharma.com |
2 |
Apr 22, 2026 |
www.fiercepharma.com |
| FDA PDUFA Dates: 6 Drug Reviews to Watch This June |
vertexaisearch.cloud.google.com |
2 |
Apr 22, 2026 |
fomatmedical.com |
| FDA Decisions Expected: April 2026 - Prime Therapeutics - Portal |
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1 |
Mar 17, 2026 |
www.primetherapeutics.com |
| New FDA Breakthrough-Drug Category — Implications for Patients |
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— |
www.nejm.org |
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| FDA Grants Breakthrough Therapy Designation to Exelixis ... |
ir.exelixis.com |
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ir.exelixis.com |
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| Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation ... |
daiichisankyo.us |
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— |
daiichisankyo.us |
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— |
www.fda.gov |
| FDA points way forward for Compass Pathways' psilocybin in treatment-resistant depression |
allsci.com |
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Apr 27, 2026 |
allsci.com |
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mindscaperetreat.com |
2 |
Apr 29, 2026 |
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| FDA Accepts NDA for Zipalertinib in Locally Advanced or Metastatic EGFR Exon 20+ NSCLC | OncLive |
onclive.com |
1 |
Apr 28, 2026 |
www.onclive.com |
| Update on FDA Advisory Committee vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR-positive breast cancer - AstraZeneca US |
astrazeneca-us.com |
2 |
Apr 30, 2026 |
www.astrazeneca-us.com |
| FDA Drug Approval Decisions Expected in October 2025 - eMPR.com |
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1 |
— |
www.empr.com |
| Ionis partner GSK announces bepirovirsen accepted for Priority Review and granted Breakthrough Therapy Designation by U.S. FDA as a potential first-in-class medicine for chronic hepatitis B | Morningstar |
morningstar.com |
1 |
Apr 28, 2026 |
www.morningstar.com |
| Axsome Therapeutics Announces FDA Approval of AUVELITY® for the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease - Investing News Network |
investingnews.com |
1 |
Apr 30, 2026 |
investingnews.com |
| Dyne Therapeutics Announces FDA Breakthrough Therapy ... |
investors.dyne-tx.com |
1 |
— |
investors.dyne-tx.com |
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ir.genmab.com |
1 |
— |
ir.genmab.com |
| Press Release: Tolebrutinib designated Breakthrough Therapy by ... |
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— |
www.sanofi.com |
| New Hope for Pancreatic Cancer With Targeted KRAS Drug |
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2 |
May 07, 2026 |
www.mskcc.org |
| FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order |
vertexaisearch.cloud.google.com |
1 |
Apr 24, 2026 |
www.fda.gov |
| FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia |
vertexaisearch.cloud.google.com |
1 |
Apr 30, 2026 |
www.fda.gov |
| FDA Grants Breakthrough Therapy Designation to TERN-701 in Ph-Positive Chronic Myeloid Leukemia - HMP Global Learning Network |
vertexaisearch.cloud.google.com |
1 |
Apr 30, 2026 |
www.hmpgloballear... |
| Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC |
vertexaisearch.cloud.google.com |
2 |
May 09, 2026 |
cancerletter.com |
| The Targeted Pulse: FDA Decisions and Breakthrough Data Shape Oncology Landscape |
targetedoncology.com |
2 |
May 03, 2026 |
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| Seizures May Signal Occult Cancer Risk, Clene Moves Toward NDA Filing for CNM-Au8, the Future of Friedreich Ataxia Care | NeurologyLive |
vertexaisearch.cloud.google.com |
1 |
May 09, 2026 |
www.neurologylive.com |
| Innovent Announces IBI363 (PD-1/IL-2α-bias Bispecific Fusion Protein) Received Third NMPA Breakthrough Therapy Designation for MSS/pMMR Metastatic Colorectal Cancer | Morningstar |
vertexaisearch.cloud.google.com |
2 |
May 11, 2026 |
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| Published FDA rejections point to manufacturing, data gaps as key stumbling blocks |
vertexaisearch.cloud.google.com |
2 |
May 11, 2026 |
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| FDA Action Update, April 2026: Acceptance, Clearance, and Complete Response Letter |
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May 01, 2026 |
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| What's Driving Axsome Therapeutics' Recent Bull Run - Kavout |
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May 08, 2026 |
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| Egetis Therapeutics to Participate in Leading International Medical Conferences in 2026 |
vertexaisearch.cloud.google.com |
1 |
May 07, 2026 |
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| Egetis Announces Grant of Patent for MCT8 Deficiency Composition in the U.S. |
vertexaisearch.cloud.google.com |
3 |
May 05, 2026 |
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| Pharma News | UCB, Pfizer, Axsome Therapeutics - DelveInsight |
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2 |
May 05, 2026 |
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| FDA Flashback: Breast Cancer Decisions and News From April 2026 - OncLive |
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May 01, 2026 |
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— |
www.hcplive.com |
| Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial - BioSpace |
biospace.com |
1 |
May 07, 2026 |
www.biospace.com |
| Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2026 Financial Results - Stock Titan |
stocktitan.net |
1 |
May 07, 2026 |
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| Palvella Q1 2026 slides: $262M cash fuels path to 2027 launch - Investing.com |
investing.com |
1 |
May 07, 2026 |
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| Iopofosine I 131 Follow-Up Data Show Strong Efficacy in Waldenström Macroglobulinemia |
targetedoncology.com |
2 |
May 05, 2026 |
www.onclive.com |
| FDA grants breakthrough status to novel therapy for hard-to-treat CML - Rare Cancer News |
rare-cancer.news |
1 |
May 04, 2026 |
rarecancernews.com |
| FDA Fast Track Designation for Oncology Drugs in April 2026 |
cancertherapyadvisor.com |
4 |
May 04, 2026 |
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fda.gov |
4 |
May 06, 2026 |
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| FDA Action Update, December 2025: Acceptance ... |
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— |
www.neurologylive.com |
| Top Breakthrough Therapy Designations of 2026 - LevelFields AI |
vertexaisearch.cloud.google.com |
3 |
May 06, 2026 |
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| Bright Uro Receives FDA Clearance For Glean® Abdominal Sensor |
www.prnewswire.com |
1 |
May 09, 2026 |
www.prnewswire.com |
| Pierre Fabre Pharmaceuticals Announces Regulatory Update Following Type A Meeting with U.S. Food and Drug Administration (FDA) on Tabelecleucel Biologic License Application (BLA) |
www.prnewswire.com |
1 |
May 09, 2026 |
www.prnewswire.com |
| FDA Green Lights Expanded Access Protocol for Daraxonrasib in Pretreated Metastatic PDAC | OncLive |
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1 |
May 01, 2026 |
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| Regulatory News & FDA Approvals - Precision Medicine Online |
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May 01, 2026 |
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| Diakonos Oncology Awarded Fast Track Designation by FDA for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma |
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1 |
May 06, 2026 |
www.prnewswire.com |
| FDA Action Update, Week of May 4, 2026: Approvals, Extended Review, and Plans for NDA Filing | NeurologyLive |
NeurologyLive |
1 |
May 12, 2026 |
www.neurologylive.com |
| Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment - Stock Titan |
Stock Titan |
1 |
May 12, 2026 |
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| Achieve Life Sciences Charts Delayed Path to Launch - TipRanks.com |
TipRanks.com |
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May 13, 2026 |
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| Three 2026 FDA Decisions Testing Whether New Drugs Can Beat Imperfect Standards: Unicycive, Protagonist And Savara ($UNCY $PTGX $SVRA) - Merlintrader Trading Pub |
merlintrader.com |
3 |
May 09, 2026 |
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| Praxis Precision Medicines Provides Corporate Update and Reports First Quarter 2026 Financial Results - Barchart.com |
barchart.com |
4 |
May 07, 2026 |
www.barchart.com |
| Oculis Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Optic Neuritis Registrational Trial - Scott Coop |
scottcoop.com |
3 |
May 07, 2026 |
www.scottcoop.com |
| FDA Action Update, Week of May 4, 2026: Approvals, Extended Review, and Plans for NDA Filing | NeurologyLive |
www.neurologylive.com |
4 |
May 12, 2026 |
www.neurologylive.com |
| Oligonucleotides Clinical Trial Drug Development Pipeline Expands with Contributions from 200+ Key Companies | DelveInsight - GlobeNewswire |
www.globenewswire.com |
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May 14, 2026 |
www.globenewswire.com |
| FDA Psychiatry Roundup: April 2026 - Medscape |
medscape.com |
2 |
May 15, 2026 |
www.medscape.com |
| Oligonucleotides Clinical Trial Drug Development Pipeline Expands with Contributions from 200+ Key Companies | DelveInsight - GlobeNewswire |
globenewswire.com |
2 |
May 14, 2026 |
www.globenewswire.com |
| Praxis Q1 loss widens as CNS pipeline advances | PRAX 8-K Filing - Stock Titan |
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May 13, 2026 |
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2 |
May 13, 2026 |
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| New FDA Drug Approvals for 2026 - Drugs.com |
www.drugs.com |
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May 13, 2026 |
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| FDA drug regulation and approval news | The Pharmaletter |
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1 |
May 16, 2026 |
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| FDA Approves AstraZeneca's Fasenra | PharmExec - Pharmaceutical Executive Daily |
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1 |
May 15, 2026 |
www.pharmexec.com |
| BioSpace - Nearly Three Quarters of FDA Breakthrough Designated Drugs Win Approval |
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1 |
Oct 09, 2025 |
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| What's New Related to Drugs - FDA |
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3 |
May 15, 2026 |
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| FDA approves AstraZeneca's new kind of hypertension drug | BioPharma Dive |
biopharmadive.com |
1 |
May 18, 2026 |
www.biopharmadive.com |
| FDA Grants Breakthrough Therapy Designation to Emi-Le for Adenoid Cystic Carcinoma |
oncologytube.com |
1 |
May 12, 2026 |
www.onclive.com |
| Belite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in Switzerland |
biospace.com |
1 |
May 19, 2026 |
www.biospace.com |
| FDA Grants Breakthrough Therapy Status to Cannabis-Derived Pain Treatment : r/TLRY - Reddit |
reddit.com |
1 |
May 18, 2026 |
www.reddit.com |
| Reed Alum's Decades-Long Pursuit of the "Undruggable" Is Paying Off |
reed.edu |
1 |
May 13, 2026 |
www.reed.edu |
| BeOne Medicines' BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma - Stock Titan |
stocktitan.net |
1 |
May 13, 2026 |
www.stocktitan.net |
| U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for the Treatment of Moderate-to-Severe Acute Pain | FirstWord Pharma |
firstwordpharma.com |
1 |
May 18, 2026 |
firstwordpharma.com |
| FDA Approves Trastuzumab Deruxtecan for Early Breast Cancer - Oncology News Central |
oncologynews.com |
1 |
May 18, 2026 |
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| Bayer Announces Positive Data for Investigational PET Radiotracer |
appliedradiology.com |
1 |
May 08, 2026 |
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| FDA clears fruit-flavored vapes, relaxes enforcement on black-market products with pending premarket applications - The Cancer Letter |
cancerletter.com |
1 |
May 16, 2026 |
cancerletter.com |
| FDA Grants Breakthrough Therapy Designation to Cannabinoid-Based Treatment |
vertexaisearch.cloud.google.com |
1 |
May 18, 2026 |
mgmagazine.com |
| FDA approves two separate indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer |
vertexaisearch.cloud.google.com |
1 |
May 16, 2026 |
www.fda.gov |
| Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack - BioSpace |
vertexaisearch.cloud.google.com |
1 |
May 19, 2026 |
www.biospace.com |
| Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack | Morningstar |
vertexaisearch.cloud.google.com |
1 |
May 19, 2026 |
www.morningstar.com |
| Achieve Life Sciences Presents Safety Data from 52 Weeks of Continuous Cytisinicline Treatment - Stock Titan |
vertexaisearch.cloud.google.com |
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May 19, 2026 |
www.stocktitan.net |
| Belite Bio Initiates NDA Submission for Tinlarebant in Stargardt Disease Type 1, Reports Q1 2026 Financial Results | Quiver Quantitative |
vertexaisearch.cloud.google.com |
2 |
May 20, 2026 |
www.quiverquant.com |
| FDA Grants Priority Review to Bayer's Asundexian for Secondary Stroke Prevention |
vertexaisearch.cloud.google.com |
2 |
May 19, 2026 |
www.neurologylive.com |
| 7 Therapies Changing Multiple Myeloma Treatment - DelveInsight |
vertexaisearch.cloud.google.com |
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May 18, 2026 |
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| Belite Bio Receives Orphan Drug Status for Tinlarebant in Stargardt Disease in Switzerland |
vertexaisearch.cloud.google.com |
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May 18, 2026 |
markets.businessi... |
| U.S. FDA Grants Priority Review to Supplemental New Drug Application for HYRNUO® (sevabertinib) Under Investigation as a First-Line Treatment of HER2-Mutated Non-Small Cell Lung Cancer - Bayer Global |
vertexaisearch.cloud.google.com |
2 |
May 18, 2026 |
www.bayer.com |
| FDA Accepts NDA for Asundexian, Dysport Noninferior Botox in Safety Profile, gMG Bridging the Gaps Discussion | NeurologyLive |
www.neurologylive.com |
2 |
May 23, 2026 |
www.neurologylive.com |
| U.S. FDA Grants Priority Review to Supplemental New Drug Application for HYRNUO® (sevabertinib) Under Investigation as a First-Line Treatment of HER2-Mutated Non-Small Cell Lung Cancer - Business Wire |
www.businesswire.com |
1 |
May 18, 2026 |
www.businesswire.com |
| FDA Breakthrough Therapy Designation Shows 72% Approval ... |
trial.medpath.com |
1 |
— |
trial.medpath.com |
| FDA Breakthrough Therapy Designation Reduced Late-Stage Drug ... |
aspe.hhs.gov |
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— |
aspe.hhs.gov |
| FDA grants Breakthrough Therapy designation for daraxonrasib in ... |
cancerletter.com |
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cancerletter.com |
| FDA Accepts NDA for Asundexian, Dysport Noninferior Botox in Safety Profile, gMG Bridging the Gaps Discussion | NeurologyLive |
neurologylive.com |
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May 23, 2026 |
www.neurologylive.com |
| 5 FDA First-in-Class Approvals in 2026: New Mechanisms, New Modalities, New Markets |
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May 21, 2026 |
www.geneonline.com |
| FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order |
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1 |
Apr 24, 2026 |
www.drugs.com |
| BeOne Medicines (ONC) FDA Approvals, PDUFA Dates & Drug Alerts 2026 - MarketBeat |
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May 23, 2026 |
www.marketbeat.com |
| Egetis to present healthcare resource drivers and cost in MCT8 deficiency at ISPOR 2026 |
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5 |
May 19, 2026 |
www.egetis.com |
| Pain FDA Breakthrough Nonopioid Investigational Therapy - Pain Medicine News |
vertexaisearch.cloud.google.com |
1 |
May 27, 2026 |
www.painmedicinenews.com |
| FDA Approves Pivekimab Sunirine for Blastic Plasmacytoid Dendritic Cell Neoplasm |
vertexaisearch.cloud.google.com |
1 |
May 27, 2026 |
www.onclive.com |
| FDA Extends Decision Date for Camizestrant in HR+ Advanced Breast Cancer With an Emergent ESR1 Mutation | OncLive |
vertexaisearch.cloud.google.com |
1 |
May 27, 2026 |
www.onclive.com |
| Brii Bio Presents Late-Breaking Data from Its Phase 2 ENSURE Study at EASL Congress 2026, Further Supporting the Potential Role of BRII-179 in Achieving Durable Immunological Control of HBV - BioSpace |
vertexaisearch.cloud.google.com |
2 |
May 27, 2026 |
www.biospace.com |
| Beyond PD-1: The drugs reshaping cancer treatment at ASCO 2026 |
vertexaisearch.cloud.google.com |
2 |
May 28, 2026 |
www.drugdiscovery... |
| FDA approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy |
vertexaisearch.cloud.google.com |
1 |
May 27, 2026 |
www.fda.gov |
| US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data - AstraZeneca US |
vertexaisearch.cloud.google.com |
1 |
May 27, 2026 |
www.astrazeneca-us.com |
| FDA's Advisory Panel Votes in Favor of Updating Covid-19 Vaccine Shots to Target XFG Variant | PharmExec |
vertexaisearch.cloud.google.com |
1 |
May 28, 2026 |
www.pharmexec.com |
| Revolution Medicines Announces FDA Breakthrough Therapy ... |
ir.revmed.com |
1 |
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ir.revmed.com |
| PharmTech's Regulatory Roundup for May 2026 | Pharmaceutical Technology |
www.pharmtech.com |
2 |
May 29, 2026 |
www.pharmtech.com |
| FDA drug regulation and approval news | The Pharmaletter |
www.thepharmaletter.com |
2 |
May 27, 2026 |
www.thepharmaletter.com |
| What's New Related to Drugs - FDA |
www.fda.gov |
3 |
May 28, 2026 |
www.fda.gov |
| 5 FDA First-in-Class Approvals in 2026: New Mechanisms, New Modalities, New Markets |
www.geneonline.news |
2 |
May 21, 2026 |
www.geneonline.news |
| FDA breaks new ground for rare disease approval pathways - MedTech Forum 2026 |
www.medtechforum.eu |
2 |
— |
www.medtechforum.eu |
| Expedited Review Pathways: 82 Drugs Designated in February 2026 - PatSnap |
www.patsnap.com |
1 |
Mar 20, 2026 |
www.patsnap.com |
| 5 FDA decisions to watch in the second quarter of 2026 - BioPharma Dive |
www.biopharmadive.com |
1 |
Jan 07, 2026 |
www.biopharmadive.com |
| FDA Action Update, April 2026: Acceptance, Clearance, and Complete Response Letter |
www.neurologylive.com |
2 |
May 01, 2026 |
www.neurologylive.com |
| FDA races to deliver BREAKTHROUGH drugs in record time |
www.youtube.com |
1 |
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www.youtube.com |