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3733 News Found

FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483


Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial
Clinical Trials | December 13, 2025

Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial

Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%


Eli Lilly’s retatrutide delivers breakthrough results in obesity & knee osteoarthritis trial
Clinical Trials | December 12, 2025

Eli Lilly’s retatrutide delivers breakthrough results in obesity & knee osteoarthritis trial

Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints


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


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


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


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


Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients
Drug Approval | December 11, 2025

Roche secures European nod for Gazyva/Gazyvaro in Lupus Nephritis patients

The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies