medtechdive18h
FDA closes 2024 with string of early alerts on device safety risks
Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.
BioPharma Dive1d
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 ...
MedCity News1d
FDA Wraps Up 2024 Handing Out Several Notable Regulatory Decisions
Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.
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.
BioSpace1d
Axsome Posts Mixed Phase III Data in Alzheimer’s Agitation, Plans FDA Filing
With two earlier trials meeting their primary endpoints, Axsome claimed it has the data to support a filing for FDA approval ...
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 ...
USA Today10d
Off-brand versions of Lilly weight loss drug must be pulled off market, could mean higher prices
According to the press release from the FDA, businesses will have between 60 and 90 days, depending on their size to stop the distribution of their off-brand products. The FDA's decision is a win ...
U.S. News & World Report8d
FDA Approves Generic GLP-1 Medicine For Diabetes Treatment
THURSDAY, Dec. 26, (2024 HealthDay News) -- The U.S. Food and Drug Administration (FDA) announced on Monday the approval of the first generic version of a daily injectable GLP-1 medicine for ...