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Results For "Food-and-Drug-Administration"

1359 News Found

Alembic Pharma receives USFDA approval for Haloperidol tablets
News | June 06, 2026

Alembic Pharma receives USFDA approval for Haloperidol tablets

The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical


Lupin secures U.S. FDA approval for interchangeable biosimilar Ranibizumab
Drug Approval | June 06, 2026

Lupin secures U.S. FDA approval for interchangeable biosimilar Ranibizumab

Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations


Aurobindo Pharma receives USFDA nod for generic Tofacitinib tablets
Drug Approval | June 05, 2026

Aurobindo Pharma receives USFDA nod for generic Tofacitinib tablets

Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval


ResMed acquires Noctrix Health for $340 million
Medical Device | June 04, 2026

ResMed acquires Noctrix Health for $340 million

Following the completion of the acquisition on June 3, Noctrix’s flagship product, Nidra will become part of ResMed’s broader sleep medicine portfolio


Lupin and Natco get FDA approval for Eribulin Mesylate injection
Drug Approval | June 03, 2026

Lupin and Natco get FDA approval for Eribulin Mesylate injection

Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai, Inc.


Granules Pharmaceuticals receives USFDA EIR for Chantilly facility
News | June 03, 2026

Granules Pharmaceuticals receives USFDA EIR for Chantilly facility

This facility plays an important role in Granules’ global manufacturing and supply network


FDA okays AstraZeneca’s bladder cancer drug Imfinzi Plus BCG
Drug Approval | June 02, 2026

FDA okays AstraZeneca’s bladder cancer drug Imfinzi Plus BCG

First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death


FDA clears Cercare Medical’s CBCT perfusion technology for real-time stroke imaging
Medical Device | June 01, 2026

FDA clears Cercare Medical’s CBCT perfusion technology for real-time stroke imaging

The technology enables clinicians to assess brain tissue and microvascular reperfusion directly in the angiography suite, potentially improving stroke treatment decisions and patient outcomes


Merck’s experimental cancer drug wins FDA breakthrough status in key lung cancer setting
Drug Approval | May 30, 2026

Merck’s experimental cancer drug wins FDA breakthrough status in key lung cancer setting

The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial


FDA greenlights AstraZeneca’s Imfinzi combo in bladder cancer breakthrough
R&D | May 30, 2026

FDA greenlights AstraZeneca’s Imfinzi combo in bladder cancer breakthrough

The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term