Latest news and insights on the pharmaceutical industry | Indian Pharma Post

Results For "US-Food-and-Drug-Administration"

197 News Found

Moderna’s mRNA flu vaccine outperforms standard shot in Phase 3 trial
Clinical Trials | May 08, 2026

Moderna’s mRNA flu vaccine outperforms standard shot in Phase 3 trial

NEJM study shows strong protection across strains


Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility
Drug Approval | May 04, 2026

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility

The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026


FDA advisory panel backs AstraZeneca prostate cancer combo in decisive vote
News | May 04, 2026

FDA advisory panel backs AstraZeneca prostate cancer combo in decisive vote

The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer


FDA okays AstraZeneca’s triple therapy Breztri for asthma
Medical Device | April 29, 2026

FDA okays AstraZeneca’s triple therapy Breztri for asthma

The aim is to simplify and strengthen long-term control of airway disease through triple therapy in one device


Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion
News | April 22, 2026

Astellas & Pfizer win FDA priority review for bladder cancer treatment expansion

A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline


Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid
Drug Approval | April 20, 2026

Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid

The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics


FDA presses 2,200+ companies to fix missing clinical trial results
News | April 15, 2026

FDA presses 2,200+ companies to fix missing clinical trial results

Move amid evidence of widespread reporting gaps


GE HealthCare and Medtronic launch real-time brain surgery imaging integration
Technology | April 12, 2026

GE HealthCare and Medtronic launch real-time brain surgery imaging integration

The Stealth AXiS surgical navigation system was recently cleared by the US Food and Drug Administration (FDA) for cranial procedures in the United States


Glenmark gets USFDA approval for generic Endometrin vaginal inserts
Drug Approval | April 09, 2026

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million