- 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 ...
On Monday, the FDA accepted Eisai Co., Ltd. (OTC:ESALY) and Biogen Inc’s (NASDAQ:BIIB) Biologics License Application (BLA) for lecanemab-irmb (Leqembi) subcutaneous autoinjector (SC-AI) for weekly ...
Regeneron Pharmaceuticals (NASDAQ:REGN) announced that the U.S. FDA has extended the target action dates for two regulatory submissions related to Eylea HD (aflibercept) injection 8 mg to the fourth ...
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.
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 ...
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 ...
BEECH ISLAND, S.C.--(BUSINESS WIRE)--Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced today that a ...
The nationwide shortage of the EpiPen is making people scramble. It’s back to school season, and a nationwide shortage of the EpiPen is making parents scramble. If you're the parent of a child with a ...
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