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11195 News Found

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


SandboxAQ, MapLight team up to target novel CNS therapy with AI-driven drug discovery
R&D | December 20, 2025

SandboxAQ, MapLight team up to target novel CNS therapy with AI-driven drug discovery

SandboxAQ will receive an upfront payment and could earn up to $200 million in milestone payments tied to preclinical, development, regulatory, and commercial achievements


Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%
Drug Approval | December 20, 2025

Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension


Briefs:  APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem
Drug Approval | December 20, 2025

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI


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


Pfizer and Cipla forge exclusive marketing and distribution pact for key brands in India
News | December 20, 2025

Pfizer and Cipla forge exclusive marketing and distribution pact for key brands in India

This marks the first partnership between Pfizer and Cipla in India


ystral expands in India with new Bangalore facility, boosting team & local production
News | December 19, 2025

ystral expands in India with new Bangalore facility, boosting team & local production

The expansion includes a larger technical and service team and increased local procurement