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Results For "U.S.-Food-and-Drug-Administration"

594 News Found

Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM
News | May 08, 2025

Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM

The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets


Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma
News | May 06, 2025

Ichnos Glenmark Innovation receives USFDA fast track designation for ISB 2001 for relapsed/refractory multiple myeloma

IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma


FDA approves Medtronic’s new Simplera Sync sensor for the MiniMed 780G system
Drug Approval | April 21, 2025

FDA approves Medtronic’s new Simplera Sync sensor for the MiniMed 780G system

The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard


ACIP votes to expand recommendation for Pfizer’s RSV vaccine ABRYSVO to include adults aged 50 – 59 at increased risk of disease
News | April 17, 2025

ACIP votes to expand recommendation for Pfizer’s RSV vaccine ABRYSVO to include adults aged 50 – 59 at increased risk of disease

Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74


Biocon Biologics secures market entry date for Yesafili in US
News | April 15, 2025

Biocon Biologics secures market entry date for Yesafili in US

YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions


FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
Drug Approval | April 12, 2025

FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer

The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date


Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s
Drug Approval | April 09, 2025

Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s

Raichur site is the group’s largest API facility and part of a wider network of seven sites


Merck seeks FDA approval for subcutaneous pembrolizumab
Drug Approval | March 29, 2025

Merck seeks FDA approval for subcutaneous pembrolizumab

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy


Abbott launches intravascular lithotripsy trial aimed at clearing coronary arteries
News | March 27, 2025

Abbott launches intravascular lithotripsy trial aimed at clearing coronary arteries

Abbott's investigational Coronary Intravascular Lithotripsy (IVL) System offers a new potential treatment by using sound pressure waves to treat arterial calcium blockages