The supplemental New Drug Application (sNDA) for the 0.1mg strength was granted Priority Review by the Food and Drug Administration (FDA). The new 0.1mg strength auto-injector has a shorter needle ...

Add Yahoo as a preferred source to see more of our stories on Google. On August 7, the U.S. Food and Drug Administration (FDA) approved the nalmefene hydrochloride auto-injector that is used in the ...

The U.S. Food and Drug Administration (FDA) has approved Richmond-based Kaléo’s supplemental drug application for the first epinephrine auto-injector specifically for infants and children with serious ...

WALTHAM, Mass., June 26, 2017 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) today announced that the U.S. Food and Drug Administration (FDA) accepted the supplemental new drug ...

Please provide your email address to receive an email when new articles are posted on . The epinephrine auto-injector AUVI-Q, used for the emergency treatment of anaphylaxis, will be available ...

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 ...

FUROSCIX Auto-injector being developed as a complement to the FUROSCIX On-body Infusor Company anticipates topline data in Q3 2024, followed by a Supplemental New Drug Application (sNDA) by year-end ...

An adrenaline auto-injector is an emergency treatment for anaphylaxis; serious and potentially fatal allergic reaction to insect stings, medicines, or food, among others. Anaphylaxis is an ...

The US Food and Drug Administration (FDA) has approved the first nalmefene hydrochloride auto-injector (Zurnai; Purdue Pharma LP) for the treatment of known or suspected opioid overdose in people aged ...

The FDA approved the first nalmefene hydrochloride auto-injector (Zurnai) for use as an emergency treatment for opioid overdose in adults and children 12 years of age and older, the agency announced ...