Most of the drug overdoses are caused by opioids or fentanyl. In a move that health experts say may reduce the number of ...
By Chris Wack Amneal Pharmaceuticals shares were up 9% after the Food and Drug Administration approved an abbreviated new drug application ...
The FDA has approved Amneal Pharmaceuticals’ ( NASDAQ: AMRX) OTC Naloxone HCl nasal spray, a generic version of the opioid ...
Approval was supported by data from a randomized, intra-patient controlled trial, which included patients with confirmed invasive breast cancer, ductal carcinoma in situ, or both. The Food and ...
The FDA has approved Alvotech’s (NASDAQ:ALVO) biosimilar of Johnson & Johnson’s (NYSE:JNJ) top-selling drug Stelara. The biosimilar, called Selarsdi, will be marketed in the US by Alvotech ...
The U.S. Food and Drug Administration (FDA) has approved a medical device named the Sepsis ImmunoScore, which is an artificial intelligence/machine learning software, to guide rapid diagnosis and ...
Jamie Raskin, D-Md., ranking member of the committee, asked the FDA what it plans to do regarding many products, including lead-contaminated cinnamon applesauce pouches that caused many children ...
The U.S. Food and Drug Administration has approved Dovato (dolutegravir/lamivudine) for adolescents living with HIV. The approval is for the treatment of HIV-1 ...
"The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial ...
Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA expanded the labels of two CAR T-cell products for multiple myeloma, allowing their use in earlier lines of ...
HER2 is a protein that stimulates quick growth of cancer cells. Its presence in solid tumor form includes biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers, according to ...