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4487 News Found

Granules Life Sciences facility receives EIR from USFDA
News | December 12, 2025

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements


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


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


Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer
Clinical Trials | December 12, 2025

Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer

The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA


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


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


Dr Agarwals Eye Hospital expands global footprint with advanced centre in Mauritius
Hospitals | December 12, 2025

Dr Agarwals Eye Hospital expands global footprint with advanced centre in Mauritius

The new centre brings advanced corneal procedures pioneered in India


Roche bags CE Mark for automated mass spectrometry antibiotics monitoring
News | December 12, 2025

Roche bags CE Mark for automated mass spectrometry antibiotics monitoring

The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics


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


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