Research & Development
US FDA Grants Approval to Sun Pharma Subsididary for Yonsa (abiraterone acetate) for Treatment of MCRPC in Combination with Methylprednisolone
25 May 2018 - - Mumbai, India-based specialty generic company Sun Pharmaceutical Industries Ltd. (NSE: SUNPHARMA, BSE: 524715) subsidiary, Princeton, New Jersey-based SPII, has received approval from ...
Cara Therapeutics grants worldwide licensing rights to commercialise its Korsuva to Vifor Fresenius
25 May 2018 - United States-based Cara Therapeutics has granted worldwide licensing rights with the exception of the US, Japan and South Korea, to Vifor Fresenius Medical Care Renal Pharma to commerci...
Cosmo Pharmaceuticals receives complete response letter from US FDA regarding Methylene Blue MMX
25 May 2018 - Ireland-based Cosmo Pharmaceuticals has received a complete response letter from the US Food and Drug Administration (FDA) stating that it cannot approve the company's Methylene Blu...
AGC Biologics to manufacture the US FDA-approved Andexxa from Portola
25 May 2018 - Therapeutic proteins company AGC Biologics stated on Thursday that it will supply the bulk drug substance for the launch of Portola Pharmaceuticals' Andexxa [coagulation factor Xa (...
The US Food and Drug Administration announces Palynziq's approval for treating phenylketonuria
25 May 2018 - Public health company The US Food and Drug Administration revealed on Thursday that it has authorised Palynziq (pegvaliase-pqpz) for adults with the rare and serious genetic disease, phe...
US FDA grants orphan-drug designation to BERG's BPM 31510
24 May 2018 - BERG LLC, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, announced yesterday that the United States Food and Drug Administrat...