FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares ...
FDA planning for fewer food and drug inspections due to layoffs, officials say
Around 170 staff were cut from the FDA's Office of Inspections and Investigations this week as part of wider cuts at U.S.
BioPharma Dive6h
FDA misses approval deadline for Novavax’s COVID-19 vaccine
The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...
How another firm's FDA approval could mean a big win for Denali Therapeutics
Key to 400-employee Denali's submission is the FDA allowing measurement of a type of GAG, called heparan sulfate, in ...
Trump begins mass layoffs at FDA, CDC, other US health agencies
Prices of Nike Jordan and Adidas Samba sneakers are likely to rise in the United States after President Donald Trump imposed ...
FDA approves first new antibiotic for UTIs in nearly 30 years
The drug Blujepa, from drugmaker GSK, provides a new treatment option as bacteria increasingly become resistant to the ...
US drug regulator delays Novavax COVID vaccine approval
The US drug regulator has missed a deadline for granting full approval to Novavax's COVID-19 vaccine, the company said ...
US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
FDA approves new drug to treat protein buildup in the heart
The FDA has approved a new drug for a serious heart condition that affects thousands of people. The drug, called Amvuttra ...
Viagra was approved by the FDA 27 years ago. It changed how we talk about sex.
Viagra was approved by the U.S. Food and Drug Administration 27 years ago. Experts say it immediately changed the way we talk ...
Verywell Health on MSN2d
A New FDA-Approved Antibiotic May Help Women With Recurring UTIs
If you deal with recurrent UTIs, a new FDA-approved antibiotic called Blujepa could offer another treatment option—especially ...