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1871 News Found

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension
News | December 12, 2025

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb


GSK’s experimental lung cancer drug gains FDA orphan drug status
Drug Approval | December 12, 2025

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization


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


New oral SERD from Roche delivers significant survival edge in early breast cancer
Clinical Trials | December 12, 2025

New oral SERD from Roche delivers significant survival edge in early breast cancer

At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival


Teva files FDA application for once-monthly schizophrenia injection
Drug Approval | December 11, 2025

Teva files FDA application for once-monthly schizophrenia injection

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time


BioNTech and Bristol Myers Squibb report punchy early results for experimental TNBC therapy
Clinical Trials | December 11, 2025

BioNTech and Bristol Myers Squibb report punchy early results for experimental TNBC therapy

The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first


Roche secures CE mark for groundbreaking Vaginitis test that promises accurate diagnosis
News | December 11, 2025

Roche secures CE mark for groundbreaking Vaginitis test that promises accurate diagnosis

Roche says its new assay “resolves this challenge by delivering accurate and specific results


Trelleborg launches Costa Rica facility to supercharge global medical device production
Medical Device | December 10, 2025

Trelleborg launches Costa Rica facility to supercharge global medical device production

The new site marks the company’s first operation in the region


Zydus launches affordable biosimilar 'Zyrifa' for cancer-related bone complications
News | December 10, 2025

Zydus launches affordable biosimilar 'Zyrifa' for cancer-related bone complications

Zyrifa is indicated for patients with bone metastases stemming from a wide range of solid tumors


Cipla launches Yurpeak (tirzepatide) for the treatment of obesity and type 2 diabetes in India
News | December 10, 2025

Cipla launches Yurpeak (tirzepatide) for the treatment of obesity and type 2 diabetes in India

Tirzepatide is the first and only dual agonist glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors