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.
Two months into the new federal fiscal year, generic approvals are faring considerably better compared to the same year-ago time frame, according to the FDA’s Generic Drug Program database. Read More
The nation’s largest pharmacy benefits manager is throwing its support behind a cheaper alternative to Turing Pharmaceuticals’ expensive toxoplasmosis/HIV treatment, threatening its monopoly on the market. Read More
The FDA has underestimated the burden that would be imposed on drug manufacturers in collecting and reporting quality metrics data, industry says in comments on the agency’s quality metrics draft guidance. Read More
In a win for branded drugmakers, President Barack Obama signed into law a bill extending the exclusivity periods for many new drugs and biologics. The measure — H.R. 639, referred to as the “Improving Regulatory Transparency for New Medical Therapies Act” — was signed into law Nov. 25, congressional records show. Read More
The FDA is receiving criticism for again delaying a final rule on generic labeling, with some accusing the agency of putting patients at risk. Read More
The UK’s Medicines and Healthcare products Regulatory Agency has given its blessing to AstraZeneca's Tagrisso as part of the Early Access to Medicines Scheme. Read More