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Regulatory Affairs

FDA Approval FDA Approval Process Animal Testing Alternatives FDA Designations Clinical Trials FDA Submissions Drug Discontinuation FDA Applications EMA Approval FDA Processes Biologics License Application RMAT Designation Clinical Study Outcomes FDA Approvals Investigational New Drug Application

7 ARTICLES

last mo.

AstraZeneca Stops Phase III Volrustomig Lung Cancer Trial

An IDMC concluded the drug combo was unlikely to meet survival endpoints in PD‑L1 negative patients, prompting the company to end the study while other volrustomig programs continue.

6 ARTICLES

2mo ago

Agenus Secures $85M Now and Up to $340M Total to Back a Registrational Colon Cancer Trial

8 ARTICLES

6mo ago

Xenon to Present Topline X-TOLE2 Phase 3 Results in Focal Onset Seizures at 8 A.M. ET Today

7 ARTICLES

7mo ago

FDA Rejects Filing of Moderna’s mRNA Flu Vaccine Over Comparator Dispute

3 ARTICLES

9mo ago

Athira Pharma Secures Exclusive Lasofoxifene Rights, Raises $90 Million to Advance Phase 3 Breast Cancer Program

3 ARTICLES

9mo ago

DBV Peanut Allergy Patch Succeeds in Pivotal Phase 3, Setting Up 2026 FDA Filing

7 ARTICLES

9mo ago

Teclistamab–Daratumumab Delivers Major Survival Gains in Relapsed Myeloma, Phase 3 Data Show

4 ARTICLES

10mo ago

Nuvalent Reports 31% ORR in Pretreated, 86% in Untreated ALK+ NSCLC With Neladalkib

9 ARTICLES

last yr.

Sanofi to Acquire Blueprint Medicines for $9.1 Billion, Boosting Its Rare Immunology Pipeline

4 ARTICLES

last yr.

Mixed Phase 3 Outcomes Cloud Future of Regeneron and Sanofi’s COPD Candidate Itepekimab