BioPharma Dive1h
FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
The American Journal of Managed Care57m
FDA Approves First Subcutaneous Nivolumab Injection in Most Solid Tumors
FDA approves the first subcutaneous version of nivolumab, making PD-1 inhibitors available to new groups of patients.
FiercePharma4h
Bristol Myers celebrates 10 years of Opdivo with FDA approval for subcutaneous version
Almost exactly 10 years after the FDA’s initial FDA approval for Bristol Myers Squibb’s Opdivo as the first PD-1 inhibitor in ...
The American Journal of Managed Care1h
FDA Approves Tislelizumab-jsgr as First-Line Therapy for HER2– Gastric Cancers
Tislelizumab-jsgr (Tevimbra) was approved in combination with chemotherapy for the treatment of unresectable or metastatic ...
FDA approves first-ever medication for obstructive sleep apnea
“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical ...
FiercePharma1h
After delay with FDA, Novartis touts pivotal trial win for intrathecal Zolgensma in older SMA patients
More than three years after Novartis’ plan for a speedy approval for intrathecal Zolgensma was thwarted by an FDA requirement ...
The FDA’s Evolving Role in Public Health
A discussion of the development of consumer protection law in the US through the enactment of key legislation and formation ...
Carrot Recall Update As FDA Sets Highest Risk Level
A Class I recall is used when "a violative product will cause serious adverse health consequences or death," according to the ...
Enchilada Recall Issued Nationwide as FDA Sets Risk Level
A nationwide recall of enchiladas has been announced after the U.S. Food and Drug Administration (FDA) identified a potential ...
FDA Announces Popular Eye Drop Recall Over Fungal Contamination
The FDA and Alcon Laboratories recalled one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count ...
FDA proposes new tests to detect asbestos in cosmetics and other products containing talc
The proposed rule is required under a law passed by Congress last year, and is intended to ensure the safety of makeup and ...
FDA begins testing aged raw cow's milk cheese samples nationwide for bird flu
The FDA announced Monday it has begun collecting samples of aged raw cow's milk cheese to test for bird flu as the U.S. battles an outbreak of the virus.