Targeting FDA user fees would leave agency gutted, experts say
Critics worry that the user fee program creates a conflict of interest between the FDA and pharmaceutical companies.
FDA approves first new UTI drug in decades
The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections, the first such drug ...
Medscape2d
Faster Cancer Drug Approvals Tied to Clinical Benefits
Researchers analyzed pivotal and confirmatory trial characteristics, outcomes, and safety data for 102 cancer drug ...
The FDA can save lives by keeping copycat drugs off the market
The United States has led the world in pharmaceutical innovation for decades by developing drugs that combat cancer, heart ...
US FDA approves first treatment for rare genetic disorder Prader-Willi syndrome
The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, ...
Here’s what to know about Blujepa, the new FDA-approved UTI treatment heading to market this year
GSK's pill, the first oral antibiotic for urinary tract infections in almost 30 years, comes as bacteria are increasingly ...
STAT7d
Alnylam drug wins FDA approval for progressive heart disease
Alnylam’s drug, vutrisiran, was approved for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM, to reduce ...
US FDA expands approval for Alnylam's drug to treat rare heart disease
U.S. Food and Drug Administration approved Alnylam's drug to treat a rare and deadly heart disease on Thursday, allowing the ...