Meridian Medical Technologies, a unit of CDMO Kindeva, snared a $129 million contract to supply the United States with the chemical nerve agent antidote autoinjector DuoDote. The FDA-approved ...
Esketamine is the first monotherapy for MDD with inadequate response to two oral antidepressants, approved after a priority FDA review. Clinical trials showed esketamine's rapid efficacy, with 22. ...
If approved, the injectable version would come packaged in an autoinjector device that allows a person to administer a shot themselves, rather than rely on a healthcare provider. The injection process ...
The product will benefit from Aktiv’s proprietary PenPal gas-driven autoinjector platform including ultra high-performance reliability and unique capabilities to accommodate any standard glass ...
The FDA has accepted Eisai and Biogen’s biologics license application for a subcutaneous autoinjector weekly maintenance dose of Leqembi for patients with mild cognitive impairment or mild ...
While Los Angeles County continues to grapple with a deadly outbreak of wildfires, a new blaze broke out in neighboring Ventura County Monday night. The Auto Fire has burned nearly 61 acres in ...
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 ...
FDA sets August 31, 2025, as the action date for Eisai and Biogen's Leqembi subcutaneous autoinjector application. Leqembi's subcutaneous dosing allows Alzheimer's patients to administer weekly ...
If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector (AI). The ...
The new fire, in Ventura County northwest of Los Angeles, covers 56 acres and is 0 percent contained, officials said. By Victor Mather Firefighters are tracking a new blaze in Southern California ...
If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The FDA has set a goal date of Aug. 31, 2025. The FDA has accepted a biologics ...