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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.

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