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3397 News Found

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B
Drug Approval | December 13, 2023

FDA and EMA accept Marstacimab regulatory submissions for the treatment of Hemophilia A and B

Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting


Zydus inks licensing agreement with Daewoong Pharmaceutical for leuprolide injectable in the US
News | December 12, 2023

Zydus inks licensing agreement with Daewoong Pharmaceutical for leuprolide injectable in the US

The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome


Wockhardt announces successful completion of pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873
News | December 12, 2023

Wockhardt announces successful completion of pivotal Phase 3 pneumonia study of its macrolide antibiotic Nafithromycin WCK 4873

The findings of Phase 3 study are in line with Phase 2 study conducted in the US and Europe


Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories
News | December 10, 2023

Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories

Dr. Reddy's Laboratories has been issued a Form 483 with three observations


Aptar Pharms opens new production facility at Taloja, Mumbai
News | December 10, 2023

Aptar Pharms opens new production facility at Taloja, Mumbai

New facility is part of Aptar Pharma’s global expansion program


Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis
Drug Approval | December 10, 2023

Astellas receives USFDA approval for expanded use of Cresemba for treatment of mucormycosis

Cresemba is the only azole antifungal therapy approved for pediatric patients as young as one affected by these serious, potentially life-threatening infections


ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346
News | December 10, 2023

ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346

First published clinical trial using live biotherapeutic candidate in Covid-19 patients suggests role in improving outcomes


Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease
Drug Approval | December 09, 2023

Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease

Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment


Zepbound is now available in US for adults living with obesity
News | December 09, 2023

Zepbound is now available in US for adults living with obesity

Express Scripts to add Zepbound to National Preferred Formulary


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Drug Approval | December 08, 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions