EVENTS44
ARTICLES23
CATEGORYMedical
Active
New drug approvals and regulatory decisions from the FDA. Includes NDA approvals, breakthrough therapy designations, and complete response letters.
LATEST EVENTS
| Entity | Type | Summary | Impact | Confidence |
|---|---|---|---|---|
| roflumilast cream | regulatory | Upcoming FDA decision for roflumilast cream for pediatric plaque psoriasis expected in Q2 2026. | medium | 95% |
| baxdrostat | regulatory | Upcoming FDA decision for baxdrostat for hypertension expected in Q2 2026. | medium | 95% |
| olezarsen | regulatory | Upcoming FDA decision for olezarsen for severe hypertriglyceridemia expected in Q2 2026. | medium | 95% |
| cytisinicline | regulatory | Upcoming FDA decision for cytisinicline for smoking cessation expected in Q2 2026. | medium | 95% |
| inhaled insulin | regulatory | Upcoming FDA decision for inhaled insulin for pediatric patients expected in Q2 2026. | medium | 95% |
| sparsentan | regulatory | Upcoming FDA decision for sparsentan in focal segmental glomerulosclerosis expected in Q2 2026. | medium | 95% |
| Praxis Precision Medicines | regulatory | Praxis Precision Medicines announced FDA acceptance and priority review of NDA for relutrigine for SCN2A and SCN8A DEEs. | high | 98% |
| Egetis Therapeutics | regulatory | Egetis Therapeutics announced FDA acceptance and priority review of NDA for Emcitate (tiratricol) for MCT8 deficiency. | high | 98% |
| RP1 | regulatory | Upcoming FDA complete response letter for RP1 in advanced melanoma expected in Q2 2026. | medium | 95% |
| trastuzumab deruxtecan | regulatory | Upcoming FDA decision on sBLA for trastuzumab deruxtecan in HER2-positive early breast cancer expected in Q2 2026. | medium | 95% |
| vepdegestrant | regulatory | Upcoming FDA decision on NDA for vepdegestrant for ESR1-mutant breast cancer expected in Q2 2026. | medium | 95% |
| sonrotoclax | regulatory | Upcoming FDA decision on NDA for sonrotoclax in relapsed/refractory mantle cell lymphoma expected in Q2 2026. | medium | 95% |
| Elevar Therapeutics | regulatory | FDA granted priority review to Elevar Therapeutics' NDA for lirafugratinib for pretreated cholangiocarcinoma, with a PDU… | high | 98% |
| Soficabtagene geleucel (WU-CART-007) | regulatory | FDA granted Breakthrough Therapy Designation to Soficabtagene geleucel (WU-CART-007) for relapsed or refractory T-cell l… | high | 98% |
| FDA | announcement | FDA Commissioner Marty Makary announced that speeding up drug approvals and increasing OTC drug availability are key age… | medium | 95% |
| trastuzumab deruxtecan | regulatory | FDA fast-tracked and granted priority review to trastuzumab deruxtecan for HER2-positive early breast cancer in March 20… | high | 98% |
| rusfertide | regulatory | FDA fast-tracked and granted priority review to rusfertide for polycythemia vera in March 2026. | high | 98% |
| lirafugratinib | regulatory | FDA fast-tracked and granted priority review to lirafugratinib for cholangiocarcinoma in March 2026. | high | 98% |
| luvesilocin | regulatory | FDA granted Breakthrough Therapy Designation to luvesilocin for postpartum depression (PPD). | high | 98% |
| milsaperidone | regulatory | FDA approved milsaperidone for schizophrenia and bipolar 1. | high | 98% |
| Avlayah | regulatory | FDA approved Avlayah for Hunter Syndrome in 2026. | high | 95% |
| Lifyorli | regulatory | FDA approved Lifyorli for platinum-resistant ovarian cancer in 2026. | high | 95% |
| Awiqli (insulin icodec-abae) | regulatory | FDA approved Awiqli (insulin icodec-abae) for type 2 diabetes in 2026. | high | 95% |
| Kresladi (marnetegragene autotemcel) | regulatory | FDA approved Kresladi (marnetegragene autotemcel) for severe Leukocyte Adhesion Deficiency-I in 2026. | high | 95% |
| Foundayo (orforglipron) | regulatory | FDA approved Foundayo (orforglipron) for weight loss in 2026. | high | 95% |
| Eli Lilly | regulatory | FDA approved Eli Lilly's Foundayo (orforglipron) for weight management under the National Priority Voucher program. | high | 98% |
| leucovorin | regulatory | FDA approved expanded use of leucovorin for cerebral folate transport deficiency in March 2026. | medium | 98% |
| tividenofusp alfa | regulatory | FDA granted accelerated approval to tividenofusp alfa for Hunter syndrome in March 2026. | high | 98% |
| Ionis Pharmaceuticals | regulatory | FDA accepted Ionis Pharmaceuticals' zilganersen NDA for priority review in Alexander disease in March 2026. | high | 98% |
| Capricor | regulatory | FDA lifted a complete response letter (CRL) for Capricor's deramiocel in March 2026. | medium | 98% |
| FORE Biotherapeutics | regulatory | FDA granted Breakthrough Therapy Designation to FORE Biotherapeutics' plixorafenib for BRAF V600E-mutated high-grade gli… | high | 95% |
| Praxis Precision Medicines | regulatory | Praxis Precision Medicines announced FDA acceptance and Priority Review of its NDA for relutrigine for SCN2A and SCN8A D… | medium | 95% |
| FDA | announcement | Amidst a turbulent year, the FDA is emphasizing efforts to speed up drug approvals through programs like the national pr… | low | 85% |
| Cogent Biosciences | regulatory | Cogent Biosciences submitted an NDA for bezuclastinib for Gastrointestinal Stromal Tumors (GIST) under the FDA's Real-Ti… | medium | 95% |
| BridgeBio Pharma | regulatory | BridgeBio Pharma submitted an NDA to the FDA for BBP-418 for limb-girdle muscular dystrophy type 2I/R9, potentially the … | medium | 95% |
| FDA | announcement | FDA Commissioner Marty Makary announced the agency's commitment to speeding up drug approvals and increasing over-the-co… | low | 90% |
| Egetis Therapeutics | regulatory | Egetis Therapeutics announced FDA acceptance and Priority Review of its NDA for Emcitate (tiratricol) for MCT8 deficienc… | medium | 95% |
| Fore Biotherapeutics | regulatory | FDA granted Breakthrough Therapy Designation to Fore Biotherapeutics' plixorafenib for adult patients with BRAF V600E–mu… | medium | 95% |
| Bristol Myers Squibb | regulatory | FDA accepted Bristol Myers Squibb's NDA for iberdomide for relapsed/refractory multiple myeloma, granting Breakthrough T… | medium | 95% |
| Eli Lilly | regulatory | Eli Lilly's orforglipron received a Commissioner's National Priority Voucher, expediting its review process prior to its… | medium | 85% |
| Orchard Therapeutics | regulatory | FDA granted accelerated approval to Orchard Therapeutics' Kresladi (marnetegragene autotemcel) for severe Leukocyte Adhe… | high | 95% |
| Eli Lilly | regulatory | FDA approved Eli Lilly's Foundayo (orforglipron) for obesity and weight-related conditions in a record 50 days under a p… | high | 100% |
| FDA | regulatory | FDA approved expanded use of leucovorin calcium tablets for cerebral folate transport deficiency, marking the first ther… | medium | 90% |
| Ionis Pharmaceuticals | regulatory | FDA accepted Ionis Pharmaceuticals' NDA for zilganersen for Alexander disease with priority review, setting a PDUFA date… | medium | 95% |
WATCHER CONFIG
query: FDA drug approval NDA breakthrough therapy designation regulatory decision
event_types: ['regulatory', 'product', 'announcement']
impact_floor: all
time_window: 7
Signal event details
FDA Drug Approvals
FIELD DATA
RAW DATA