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.
Lawmakers voted last night to fund the federal government with a $1.5 trillion, 2,700-page omnibus package that includes emergency aid for Ukraine and funds the government for the rest of fiscal 2022. Read More
In a revised draft guidance released yesterday, the FDA outlined its latest thinking on prescription drug supply-chain verification systems that companies will need to implement to comply with the Drug Supply Chain Security Act (DSCSA), which goes into effect in November 2023. Read More
Drugmaker Catalent Massachusetts drew a Form 483 with four observations following an FDA inspection of its Chelsea, Mass., drug manufacturing facility. Read More
Efanesoctocog alfa, a bioengineered clotting factor being co-developed by Sanofi and Sobi, practically eliminated bleeding episodes in patients with hemophilia A who took it as a prophylactic weekly injection. Read More
Despite pushing for greater clinical trial participation of minority patients via a five-year action plan, the FDA’s efforts appear to have made little difference for Black patients, the latest analysis has found. Read More
The changes the agency is considering would involve less standardization of “quality metrics and definitions” and allow facilities more leeway. Read More
Novartis and Voyager Therapeutics have joined forces to develop adenovirus viral vectors (AAV) that could cross the blood-brain barrier, potentially delivering gene therapy deep into the brain. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) is about to start two pilot projects on drug manufacturing inspections, a senior industry official said. Read More