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Results For "Food-and-Drug-Administration"

1335 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


Merck completes $5.8 billion acquisition of Terns Pharma
News | May 07, 2026

Merck completes $5.8 billion acquisition of Terns Pharma

At the center of the deal is TERN-701, a drug recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for adults with Philadelphia chromosome-positive chronic myeloid leukemia


Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility
Biopharma | May 06, 2026

Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility

The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026


Caplin Steriles receives USFDA approval for Calcium Gluconate Injection
Drug Approval | May 06, 2026

Caplin Steriles receives USFDA approval for Calcium Gluconate Injection

Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million


Lupin receives USFDA approval for generic Ravicti oral liquid
Drug Approval | May 05, 2026

Lupin receives USFDA approval for generic Ravicti oral liquid

Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders


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 renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win
News | May 02, 2026

FDA renews IQOS “reduced-risk” status backing PMI’s smoke-free strategy in regulatory win

The renewal covers two versions of the IQOS device and three HEETS tobacco variants


Microbot Medical Inc. appoints Alon Tamir as VP Sales EMEA
People | May 01, 2026

Microbot Medical Inc. appoints Alon Tamir as VP Sales EMEA

Tamir brings more than 20 years of experience in the medical technology sector