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

487 News Found

Pfizer’s Braftovi combination regime reduces death risk  for patients with  BRAF V600E mutant mCRC
Diagnostic Center | May 31, 2025

Pfizer’s Braftovi combination regime reduces death risk for patients with BRAF V600E mutant mCRC

Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment


Merck withdraws Biologics License Application for Patritumab Deruxtecan
Drug Approval | May 30, 2025

Merck withdraws Biologics License Application for Patritumab Deruxtecan

The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance


Venus Remedies joins United Nations Global Compact
Sustainability | May 21, 2025

Venus Remedies joins United Nations Global Compact

This global affiliation marks a critical step in the company’s mission to create long-term value through ethical practices, scientific innovation, and inclusive healthcare delivery


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