Login to Your Account



Regulatory NEWS

Bayer AG's P13K inhibitor, copanlisib, won FDA approval Thursday for use in adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.

Reflecting a record-high workload at the FDA's drug center, the reconstructed PDUFA fees for fiscal 2018 will have to generate more than $911 million in revenue over the next year.

Shingrix (varicella zoster vaccine [recombinant], adjuvanted) from Glaxosmithkline plc sailed through a hearing by the FDA's Vaccines and Related Biological Products Committee, with panelists voting 11-0 in favor of the product's efficacy and safety in people 50 years of age and beyond.

More Regulatory Headlines

Cast Your Vote

Should there be restrictions on the use of gene-editing technology?: