Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 37

Results For "ANDA"

2590 News Found

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


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


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


Lilly drug cuts risk of disease progression or death by 80% in trial
Clinical Trials | December 11, 2025

Lilly drug cuts risk of disease progression or death by 80% in trial

The company has unveiled the results of pirtobrutinib from its BRUIN CLL-313 study


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


Bristol Myers Squibb unveils breakthrough Lymphoma data
News | December 11, 2025

Bristol Myers Squibb unveils breakthrough Lymphoma data

Golcadomide, a CELMoD agent, continued to deliver deep and durable responses in aggressive B-cell and follicular lymphomas