The Food and Drug Administration has approved an auto-injector developed by a Richmond pharmaceutical company for emergency treatment of an overdose involving powerful painkillers. EVZIO is a ...

The FDA’s drug review process can often be "unpredictable," and review teams typically “differ greatly” in what they ask of drug sponsors, Sen. Bill Cassidy said.

- UDENYCA ® is the only pegfilgrastim therapy delivered in a convenient, easy-to-administer prefilled autoinjector to offer in-clinic and at-home administration options for cancer patients undergoing ...

The FDA approved dihydroergotamine (DHE) mesylate injection (Brekiya) to treat acute migraine (with or without aura) and cluster headaches in adults, Amneal Pharmaceuticals announced Thursday. The ...

Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESAIY) announced the rolling submission of a marketing application to receive an FDA label expansion for a subcutaneous autoinjector that delivers their Alzheimer ...

Aiming to deliver blockbuster sales of its Alzheimer’s-disease-fighting antibody Leqembi in its 2027 fiscal year, Eisai has cleared a key regulatory hurdle in its quest to grow the medicine's reach.

Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. FDA has accepted Eisai's Biologics License Application for lecanemab-irmb, marketed as LEQEMBI, which is designed for subcutaneous ...