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.
The FDA has thrown a wrench into Chiasma’s plans to market Mycapssa, the company’s acromegaly candidate, issuing a complete response letter that asks for more data. Read More
The World Health Organization is calling for stricter enforcement of private vaccine management regulations in China to mirror the tight controls the country has over its public vaccine distribution system. Read More
European regulators have signed off on Teva Pharmaceutical Industries’ planned $40.5 billion purchase of Allergan’s generics unit, provided the company sells off numerous overlapping product areas to address anti-competitive concerns. Read More
To provide a more unified approach in evaluating biosimilars, India’s Central Drugs Standard Control Organization is requiring sponsors to conduct equivalence, non-inferiority or comparability Phase 3 clinical trials. Read More
The FDA is looking to shed light on the sometimes murky rules governing compounding operations to distinguish heavily regulated outsourcing facilities from tiny compounding operations that are lightly regulated. Read More