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FDA Approval

Drug Approval Process Biologics License Application Drug Development New Drug Application Medical Devices Drug Applications Priority Review Drug Safety Drug Review Process Accelerated Approval

8 ARTICLES

2w ago

FDA Panel Votes Against Deramiocel Despite Lancet Publication of Positive Phase 3 HOPE‑3 Results

The advisory committee’s 9–3 vote deepens a split between agency reviewers and the peer‑reviewed trial findings and leaves a final FDA decision set for August 22, 2026.

4 ARTICLES

2w ago

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

5 ARTICLES

2mo ago

FDA Accepts Roche’s Tecentriq for Priority Review in dMMR Stage III Colon Cancer

7 ARTICLES

2mo ago

New Oral Drug Nearly Doubles Survival for Treated Metastatic Pancreatic Cancer

3 ARTICLES

2mo ago

U.S. Biotech Reports Major Survival Gain in Pancreatic Cancer as Hiroshima Plans 2028 Trial for MicroRNA Mesothelioma Drug

3 ARTICLES

2mo ago

FDA Approves Xocova as First Oral Post-Exposure COVID-19 Prophylaxis

6 ARTICLES

2mo ago

Daraxonrasib Doubles Survival in Second‑Line Metastatic Pancreatic Cancer

3 ARTICLES

2mo ago

Lorundrostat Produces Blood-Pressure and Albuminuria Drops in Company Post Hoc Phase 3 Analysis

6 ARTICLES

2mo ago

FDA Accepts ImmunityBio Filing to Expand ANKTIVA Use in Bladder Cancer

4 ARTICLES

3mo ago

Milestone Posts Q1 Loss as CARDAMYST Launch Shows Early Uptake and AFib-RVR Phase 3 Begins

3 ARTICLES

3mo ago

Moderna’s mRNA Flu Shot Tops Standard Vaccine in Large Phase 3 Trial

7 ARTICLES

3mo ago

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

8 ARTICLES

3mo ago

FDA Approves Auvelity as First Non‑Antipsychotic for Alzheimer’s Agitation

3 ARTICLES

3mo ago

Pfizer’s Elrexfio Posts Phase 3 PFS Win Over Standard Multiple Myeloma Regimen

3 ARTICLES

3mo ago

Intellia’s Gene-Editing Drug Cuts HAE Attacks 87% in Phase 3 as FDA Filing Begins

FDA Approval

FDA Panel Votes Against Deramiocel Despite Lancet Publication of Positive Phase 3 HOPE‑3 Results

FDA Licenses Ezplaz as First U.S. Freeze-Dried Plasma for Adult Transfusion

AstraZeneca Licenses Global Rights to Zegfrovy From Dizal

FDA Approves At‑Home Weekly Subcutaneous Starter Dose for Leqembi

FDA Grants Priority Review to Roche’s Enspryng for Thyroid Eye Disease

FDA Approves Lumvoa for Thyroid Eye Disease

FDA Agrees Three‑Year Phase I/II Data Can Support uniQure’s AMT‑130 Accelerated BLA

FDA Accepts Roche’s Tecentriq for Priority Review in dMMR Stage III Colon Cancer

New Oral Drug Nearly Doubles Survival for Treated Metastatic Pancreatic Cancer

U.S. Biotech Reports Major Survival Gain in Pancreatic Cancer as Hiroshima Plans 2028 Trial for MicroRNA Mesothelioma Drug

Never miss stories about

FDA Approval

FDA Approves Xocova as First Oral Post-Exposure COVID-19 Prophylaxis

Daraxonrasib Doubles Survival in Second‑Line Metastatic Pancreatic Cancer

Lorundrostat Produces Blood-Pressure and Albuminuria Drops in Company Post Hoc Phase 3 Analysis

FDA Accepts ImmunityBio Filing to Expand ANKTIVA Use in Bladder Cancer

Milestone Posts Q1 Loss as CARDAMYST Launch Shows Early Uptake and AFib-RVR Phase 3 Begins

Moderna’s mRNA Flu Shot Tops Standard Vaccine in Large Phase 3 Trial

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

FDA Approves Auvelity as First Non‑Antipsychotic for Alzheimer’s Agitation

Pfizer’s Elrexfio Posts Phase 3 PFS Win Over Standard Multiple Myeloma Regimen

Intellia’s Gene-Editing Drug Cuts HAE Attacks 87% in Phase 3 as FDA Filing Begins

Never miss stories about

FDA Approval