We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Ascent Pharmaceuticals, a drug manufacturer in Central Islip, New York, drew a Form 483 after the FDA observed deficiencies at its facility, including a failure to check the effectiveness of corrective and preventive actions (CAPAs). Read More
Bristol Myers Squibb has withdrawn the U.S. indication for its blockbuster drug Opdivo (nivolumab) for treatment of small cell lung cancer, following disappointing clinical trial results. Read More
A federal appeals court ruling last year against Teva Pharmaceuticals threatens other generic drugmakers, according to an amicus brief filed Dec. 22 by a roll call of professors of law, economics, business, health and medicine. Read More
India’s Bharat Biotech has finalized enrollment for a phase 3 trial of its COVID-19 vaccine, Covaxin, which Indian regulators approved Jan. 3 for emergency use. Read More
A small randomized trial in Argentina has found that the early use of convalescent plasma in COVID-19-infected adults helped to reduce progression to severe disease. Read More
German vaccine developer CureVac has secured a deal with Bayer to help gain regulatory approvals worldwide for its messenger RNA-based COVID-19 vaccine candidate, CVnCoV. Read More
Scientists are closely monitoring the potential impact of mutations of the SARS-CoV-2 virus on the effectiveness of COVID-19 vaccines, but for the moment the new strains don’t appear able to completely evade their protective effect. Read More