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4185 News Found

Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial
News | December 12, 2025

Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial

Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug


FDA fast-tracks first drug nod under new national priority voucher program
News | December 12, 2025

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals


Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO
Clinical Trials | December 12, 2025

Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO

The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA


Neurizon’s ALS drug regimen cleared for launch in Healey platform trial
Clinical Trials | December 12, 2025

Neurizon’s ALS drug regimen cleared for launch in Healey platform trial

The Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled


$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing
Biopharma | December 12, 2025

$22 million BARDA project taps ProteoNic Tech to boost life-saving monoclonal antibody manufacturing

The multi-partner team will integrate new technologies across the entire mAb production workflow, from cell line development to purification


Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma
Drug Approval | December 12, 2025

Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma

The FDA aims to make a decision by April 8, 2026


FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034
News | December 12, 2025

FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034

The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034


OTR Therapeutics and Zealand Pharma join forces to target metabolic diseases
R&D | December 12, 2025

OTR Therapeutics and Zealand Pharma join forces to target metabolic diseases

The companies aim to expand treatment options for millions living with metabolic disorders


Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe
News | December 12, 2025

Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe

This is the first approval of a prescription transdermal dosage Form in the European markets from this facility


Senores Pharmaceuticals launches of Deferiprone Tablets USP, 500 mg & 1000 mg
News | December 12, 2025

Senores Pharmaceuticals launches of Deferiprone Tablets USP, 500 mg & 1000 mg

The product will be marketed by Dr. Reddy's Laboratories Inc.