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 ...
The FDA issued the advisory about the frozen, raw half-shell oysters from South Korea last week, after the California Department of Public Health advised the agency of a norovirus outbreak.
(NEXSTAR) – The Food and Drug Administration (FDA) announced Monday that two heart pump products are being recalled after reports of 14 deaths and hundreds of injuries were associated with the ...
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 ...
A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA's most serious recall, the agency announced Monday. The recall comes years after surgeons say ...
Basilea’s Zevtera gets U.S. FDA approval for MRSAB and other severe infections Zevtera – A New antibiotic therapy for antimicrobial-resistant infections (AMR), especially those caused by ...
The FDA will continue to actively investigate how WanaBana’s apple cinnamon fruit puree pouches, which were recalled in late October because of high lead levels, became contaminated. However ...
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 ...
House approves renewal of warrantless surveillance program after intense fight over changes, sending bill to the Senate WASHINGTON -- House approves renewal of warrantless surveillance program ...
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 ...