Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 132

Results For "FDA"

2290 News Found

Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management
Drug Approval | December 23, 2025

Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management

Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial


Altimmune’s Pemvidutide shows positive topline results from IMPACT Phase IIb trial
Clinical Trials | December 22, 2025

Altimmune’s Pemvidutide shows positive topline results from IMPACT Phase IIb trial

The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile


Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus
Clinical Trials | December 21, 2025

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus

The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation


Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch
News | December 21, 2025

Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026


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


Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity
Drug Approval | December 20, 2025

Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity

The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,


Gilead’s new HIV therapy shows promising Phase 3 results
Clinical Trials | December 19, 2025

Gilead’s new HIV therapy shows promising Phase 3 results

The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy


Immunome’s Varegacestat shows dramatic results in Phase 3 desmoid tumor trial
Clinical Trials | December 19, 2025

Immunome’s Varegacestat shows dramatic results in Phase 3 desmoid tumor trial

The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival


Roche unveils major upgrade to cobas 6800/8800 systems, boosting lab efficiency
Digitisation | December 19, 2025

Roche unveils major upgrade to cobas 6800/8800 systems, boosting lab efficiency

The update promises to revolutionize laboratory workflows by optimizing resources