EVENTS399
ARTICLES237
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 |
|---|---|---|---|---|
| FDA | regulatory | FDA is anticipated to approve several new drugs and expanded uses for existing medications, including Ozempic, Mounjaro,… | medium | 95% |
| GoodRx | announcement | GoodRx published a report highlighting several highly anticipated drugs, including Ozempic and CagriSema, pending FDA ap… | medium | 90% |
| FDA | regulatory | The FDA's CDER released its 13th annual report, "Advancing Health Through Innovation: New Drug Therapy Approvals 2023," … | high | 95% |
| Drug Hunter | announcement | Drug Hunter published an article reviewing novel small molecule FDA drug approvals that occurred in 2025. | low | 80% |
| FDA | regulatory | The FDA is expected to consider approval for several highly anticipated treatments, including Ozempic, Mounjaro, and Cag… | medium | 90% |
| FDA | regulatory | The FDA introduced the breakthrough therapy designation to accelerate drug development for serious conditions, aiming to… | medium | 90% |
| Genentech | regulatory | Genentech's New Drug Application (NDA) for its oral breast cancer drug, giredestrant, was accepted by the FDA for priori… | high | 100% |
| Immix Biopharma, Inc. | regulatory | Immix Biopharma received U.S. FDA Breakthrough Therapy Designation for its drug NXC-201 based on positive Phase 2 clinic… | high | 100% |
| Novartis | regulatory | Novartis's ianalumab received FDA Breakthrough Therapy designation for Sjögren’s disease, expediting its development and… | high | 100% |
| FDA | regulatory | FDA introduced the Breakthrough Therapy designation program in 2012 to expedite drug development and review. | high | 80% |
| Zavabresib | regulatory | FDA granted Orphan Drug Designation to zavabresib, an investigational therapy for myelofibrosis. | medium | 90% |
| Orca-T | regulatory | FDA extended the review deadline for Orca-T for myelodysplastic syndromes and acute leukemias to July 6, 2026. | medium | 90% |
| CB-011 | regulatory | CB-011, an allogeneic CAR T product, received FDA RMAT designation for relapsed/refractory multiple myeloma. | medium | 90% |
| Companies developing psychedelic medicines | regulatory | FDA issued national priority vouchers to three companies for fast-track review of psychedelic-based medicines. | high | 90% |
| DiaMedica Therapeutics Inc. | announcement | DiaMedica Therapeutics granted stock options to a newly hired non-executive employee as a material inducement. | low | 90% |
| FDA | regulatory | FDA granted Priority Review designation to five drugs, accelerating their examination for potential early regulatory app… | high | 100% |
| FDA | regulatory | FDA introduced the "breakthrough therapy" designation in July 2012 to accelerate the development and approval of promisi… | high | 100% |
| FDA | announcement | FDA's Center for Drug Evaluation and Research announced 24 new drug approvals thus far in 2026. | low | 80% |
| Merck & Co., Inc. | regulatory | FDA granted Breakthrough Therapy Designation to Merck's Raludotatug Deruxtecan for platinum-resistant ovarian cancer. | high | 100% |
| BMJ Publishing Group Ltd | announcement | BMJ published an analysis discussing potential confusion between FDA breakthrough therapy designation and consumer drug … | low | 90% |
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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