USA – CDER approved 50 novel drugs in 2024, record number of biosimilars
Innovation Across Medical Conditions
In 2024, we approved 50 new drugs never before approved or marketed in the U.S.,
known as “novel” drugs. We also made...
UK – NICE recommends olaparib for BRCA-mutated breast cancer treatment
The National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Lynparza (olaparib) for NHS use in England and Wales.
This...
UK – AstraZeneca’s Lynparza recommended by NICE to treat advanced breast cancer
The health technology assessment agency has recommended that the drug be used on the NHS in England and Wales to treat adults with HER2-negative,...
USA – FDA finalizes advanced manufacturing technology designation guidance
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors interested in participating in the Advanced Manufacturing Technology (AMT) designation...
USA – FDA proposes update to 18-year guidance on developing weight loss drugs
The US Food and Drug Administration (FDA) has published draft guidance for sponsors developing drugs and biologics for weight reduction for patients who are...
USA – AI in drug development: FDA draft guidance addresses product lifecycle, risk
The US Food and Drug Administration (FDA) has released a new draft guidance on the use of artificial intelligence (AI) that produces data or...
USA – Batch uniformity: FDA details testing approaches for continuous manufacturing, 3D printing
The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under...
Europe – A common EU approach to data transparency in medicine regulation
EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and...
Europe – Successful pilot paves the way for implementation of ePI
The report of a pilot exploring the creation and testing of ePIs (electronic product information) in real regulatory procedures was published today. The pilot...
Europe – First medicine to treat rare genetic disorder causing cysts and tumours
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Welireg (belzutifan) in adults with certain von Hippel-Lindau (VHL) disease-associated tumours and...
