News | August 28, 2025
FDA approves Coya Therapeutics’ trial of COYA 302 for ALS
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Dr. Reddy’s becomes the first pharmaceutical company to receive regulatory approval to launch Linaclotide in India under the brand name Colozo
The first pillar is advanced manufacturing, focused on upgrading existing CDMO
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
The $700 million project is part of Roche’s $50 billion investment in US manufacturing, infrastructure and R&D
Investment supports Company’s plans to manufacture the vast majority of advanced medicines in the U.S. to meet the needs of patients in the U.S.
The company is bringing precision therapies for gynaecological cancers
Anthony brings more than 25 years of pharmaceutical development and CRO experience to his expanded role
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