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Results For "approval"

2614 News Found

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


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,


GSK’s Exdensur gains FDA nod for severe asthma with just two doses a year
Drug Approval | December 20, 2025

GSK’s Exdensur gains FDA nod for severe asthma with just two doses a year

The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials


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


Novo Nordisk files FDA application for once-weekly obesity drug CagriSema
News | December 19, 2025

Novo Nordisk files FDA application for once-weekly obesity drug CagriSema

If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection


AstraZeneca India receives permission from CDSCO for Datopotamab Deruxtecan powder
Drug Approval | December 18, 2025

AstraZeneca India receives permission from CDSCO for Datopotamab Deruxtecan powder

The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) in India


Astellas & Pfizer report breakthrough Phase 3 results in muscle-invasive bladder cancer
Clinical Trials | December 18, 2025

Astellas & Pfizer report breakthrough Phase 3 results in muscle-invasive bladder cancer

The combination also outperformed chemotherapy on another important secondary endpoint


FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer
Drug Approval | December 18, 2025

FDA nod to Johnson & Johnson’s AKEEGA for aggressive prostate cancer

Patients with BRCA mutations often face aggressive disease and poor prognosis


Glenmark secures exclusive multi-regional rights to Aumolertinib from Hansoh Pharma
News | December 17, 2025

Glenmark secures exclusive multi-regional rights to Aumolertinib from Hansoh Pharma

Hansoh Pharma will receive an upfront payment in the low double-digit millions