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229 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


Apitoria Pharma receives 3 observations from USFDA for Unit-V
Drug Approval | December 12, 2025

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines


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


Roche’s Columvi combo doubles survival in hard-to-treat lymphoma
Clinical Trials | December 09, 2025

Roche’s Columvi combo doubles survival in hard-to-treat lymphoma

Columvi combined with gemcitabine and oxaliplatin dramatically extends survival in people with relapsed or refractory diffuse large B-cell lymphoma


Bayer reports promising results for low-dose pediatric MRI contrast agent
Clinical Trials | December 07, 2025

Bayer reports promising results for low-dose pediatric MRI contrast agent

MRI is particularly valuable in pediatric care due to its non-invasive nature


Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis
Clinical Trials | December 04, 2025

Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis

The company is excluding data from the affected sites to maintain the study's integrity


EU greenlights Dupixent for chronic urticaria, offering new hope to patients
Drug Approval | November 27, 2025

EU greenlights Dupixent for chronic urticaria, offering new hope to patients

It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria