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

Results For "(FDA"

639 News Found

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke
Clinical Trials | February 07, 2026

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke


SPARC announces receipt of priority review voucher associated with Sezaby approval
News | February 04, 2026

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases


Eyestem moves closer to blindness breakthrough with phase 2 trial green light
R&D | January 29, 2026

Eyestem moves closer to blindness breakthrough with phase 2 trial green light

The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity


Sun Pharma launches Unloxcyt for advanced cutaneous squamous cell carcinoma treatment
News | January 16, 2026

Sun Pharma launches Unloxcyt for advanced cutaneous squamous cell carcinoma treatment

UNLOXCYT is an evolution in checkpoint inhibition and is now available for the treatment of adults in the U.S. with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation


EMA and FDA unveil joint AI principles to transform drug revelopment
R&D | January 16, 2026

EMA and FDA unveil joint AI principles to transform drug revelopment

Experts caution that realizing AI’s potential requires careful management and risk mitigation


Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR
Drug Approval | January 09, 2026

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million


Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China
Biopharma | January 07, 2026

Kelun-Biotech secures IND nod for innovative cancer therapy SKB105 in China

Kelun-Biotech and Crescent Biopharma forged a collaboration covering SKB105/CR-003 and SKB118, a PD-1 x VEGF bispecific antibody also known as CR-001


FDA setback for Sanofi’s Tolebrutinib in progressive MS
Drug Approval | December 27, 2025

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity


Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Drug Approval | December 22, 2025

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia


EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease
Drug Approval | December 20, 2025

EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD