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Results For "USFDA"

1404 News Found

FDA okays Eli Lilly’s new weight-loss pill, expanding options for millions
News | April 02, 2026

FDA okays Eli Lilly’s new weight-loss pill, expanding options for millions

The approval is backed by results from Lilly’s ATTAIN clinical trial program, which showed significant weight loss among participants


Rusan unveils APOSAN 3ml multi-dose pen
News | April 01, 2026

Rusan unveils APOSAN 3ml multi-dose pen

The company now offers the complete range of Apomorphine Hydrochloride in different fill volumes


Lupin receives FDA’s tentative approval for Sugammadex injection
Drug Approval | March 31, 2026

Lupin receives FDA’s tentative approval for Sugammadex injection

Sugammadex injection is bioequivalent to Merck’s Bridion injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery


HRV Pharma and Shodhana Laboratories forge CDMO Alliance
News | March 31, 2026

HRV Pharma and Shodhana Laboratories forge CDMO Alliance

The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework


Granules Life Sciences receives VAI Classification for Shamirpet facility
News | March 31, 2026

Granules Life Sciences receives VAI Classification for Shamirpet facility

The inspection is now closed, and no regulatory action has been recommended


Rocket Pharma gets FDA nod for first pediatric gene therapy targeting severe LAD-I
R&D | March 29, 2026

Rocket Pharma gets FDA nod for first pediatric gene therapy targeting severe LAD-I

The approval covers pediatric patients without a matched sibling donor for stem cell transplant


Dr. Reddy’s Laboratories launches India’s first DCGI-approved Semaglutide injection ‘Obeda’ for type 2 diabetes
News | March 21, 2026

Dr. Reddy’s Laboratories launches India’s first DCGI-approved Semaglutide injection ‘Obeda’ for type 2 diabetes

The announcement marks Dr. Reddy’s Day?1 entry into the GLP?1 receptor agonists therapy space and readiness to serve patients in India


Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU
News | March 21, 2026

Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU

These approvals represent a defining moment for people living with classical Hodgkin Lymphoma


Glenmark Therapeutics USA launches fluticasone propionate nasal spray
News | March 20, 2026

Glenmark Therapeutics USA launches fluticasone propionate nasal spray

The Flonase Allergy Relief Nasal Spray, 50 mcg per spray market achieved annual sales of approximately $384.7 million


QIAGEN bags FDA nod for full GI testing on QIAstat-Dx Rise system
News | March 16, 2026

QIAGEN bags FDA nod for full GI testing on QIAstat-Dx Rise system

The approval means US laboratories can now run both respiratory and gastrointestinal panels on the high-throughput QIAstat-Dx Rise