FDA’s tobacco unit pledges reset after criticism
By MATTHEW PERRONE - AP Health Writer
WASHINGTON (AP) — Food and Drug Administration officials on Friday pledged a reset in the agency’s tobacco…
Browsing Tag
FDAs
FDA’s own reputation could be restraining its misinfo fight
By MATTHEW PERRONE - AP Health Writer
WASHINGTON (AP) — The government agency responsible for tracking down contaminated peanut butter and defective…
Entera Bio Announces FDA’s Acceptance of a Type D Meeting Review to Affirm Design of…
<!-- Name:DistributionId Value:8750087 -->
<!-- Name:EnableQuoteCarouselOnPnr Value:False -->…
FDA’s advisers back plan to simplify COVID-19 vaccinations
By LAURAN NEERGAARD - AP Medical Writer
The U.S. is poised to make COVID-19 vaccinations more like a yearly flu shot, a major shift in strategy despite…
Pathway Development Consortium Announces Publication in Human Gene Therapy on the…
- Publication in Human Gene Therapy provides rationale for the use of microdystrophin expression levels as a surrogate endpoint reasonably likely to predict clinical benefit for AAV gene…
The FDA’s power to approve drugs faces sweeping challenge in lawsuit seeking to…
Mifepristone (Mifeprex) and Misoprostol, the two drugs used in a medication abortion, are seen at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa…
Catalyst Pharmaceuticals Comments on FDA’s Announcement of its Position on…
Announced Earlier Today-Notice Received from ANDA Filer for FIRDAPSE® CORAL GABLES, Fla., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ: CPRX), a…
What the FDA’s accelerated approval of a new Alzheimer’s drug could mean…
The U.S. Food and Drug Administration approved the medication lecanemab, sold under the brand name Leqembi, on Jan. 6, 2023, through an “accelerated approval pathway” that fast-tracks…
What the FDA’s rule changes allowing the abortion pill mifepristone to be…
In early January 2023, the U.S. Food and Drug Administration modified its rules for mifepristone, a drug used for medication abortion, allowing it to be offered with a prescription by…
Opinion | FDA’s Proposed LASIK Warning May Leave Patients Less Informed
LASIK surgery has been studied continuously since the FDA approved the procedure nearly a…