EVENTS291
ARTICLES163
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 |
|---|---|---|---|---|
| Revolution Medicines | regulatory | Revolution Medicines received FDA Breakthrough Therapy Designation for elironrasib for KRAS G12C-mutated NSCLC. | high | 95% |
| FDA | announcement | FDA Commissioner discussed the agency's push to fast-track life-saving drugs and deliver faster cures. | low | 80% |
| Axsome Therapeutics | regulatory | The FDA approved Axsome Therapeutics' AXS-05 (Auvelity) for agitation in patients with dementia due to Alzheimer's disea… | high | 95% |
| Ultragenyx | regulatory | The FDA accepted Ultragenyx's resubmitted BLA for UX111, a gene therapy for MPS IIIA, with a PDUFA date of Sep 19, 2026. | medium | 90% |
| FDA | regulatory | The FDA lowered pivotal trial requirements, awarded more special vouchers, and spotlighted a new approval framework for … | medium | 85% |
| — | regulatory | 82 drugs received expedited review designations (Orphan Drug, Breakthrough Therapy, Priority Review) across multiple reg… | low | 80% |
| FDA | announcement | The FDA is prioritizing innovative therapies for rare diseases, streamlining processes and review times. | medium | 80% |
| FDA | regulatory | The FDA renewed its commitment to flexibility in CMC requirements for cell and gene therapies in January 2026. | medium | 85% |
| FDA | announcement | The FDA approved five first-in-class drugs in the first five months of 2026, exceeding the historical average. | medium | 85% |
| — | regulatory | The FDA approved Otarmeni (lunsotogene parvec-cwha) as the first gene therapy for genetic hearing loss. | high | 90% |
| FDA | regulatory | The FDA issued several guidance documents in May, including those related to bioequivalence studies. | low | 80% |
| — | regulatory | The FDA approved pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic mal… | high | 90% |
| AstraZeneca | regulatory | The FDA approved durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cance… | high | 90% |
| AstraZeneca | regulatory | The FDA delayed a decision on AstraZeneca's camizestrant New Drug Application (NDA). | medium | 90% |
| AstraZeneca, Daiichi Sankyo | regulatory | AstraZeneca and Daiichi Sankyo received US approval for Datroway for first-line treatment of unresectable or metastatic … | high | 95% |
| Gilead | regulatory | The FDA granted accelerated approval for Gilead's Hepcludex (Bulevirtide) for chronic hepatitis delta virus (HDV) infect… | high | 95% |
| — | regulatory | The FDA approved Bizengri for an ultra-rare aggressive cancer in the bile ducts. | high | 90% |
| FDA | regulatory | FDA's advisory panel recommended updating COVID-19 vaccine shots to target the XFG variant for the 2026-2027 season. | medium | 90% |
| AstraZeneca | regulatory | The FDA extended the PDUFA date for AstraZeneca's camizestrant NDA review to allow for additional data submission. | medium | 90% |
| AbbVie, Inc. | regulatory | The FDA approved AbbVie's pivekimab sunirine-pvzy (Decnupaz) for adults with blastic plasmacytoid dendritic cell neoplas… | high | 100% |
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
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