Convicted drug trafficker on supervised release indicted for allegedly having guns, cocaine, pills
A Norwich man has pleaded not guilty to charges stemming from an indictment charging him with having cocaine, narcotic pills ...
Healio3h
FDA grants priority review to oral non-small cell lung cancer drug
The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...
Health Advocates Are Unhappy with FDA Guidance on Lead Levels in Baby Food
TUESDAY, Jan. 7, 2025 (HealthDay News) -- The U.S. Food and Drug Association (FDA) released the first-ever guidelines for ...
BioSpace2d
5 FDA Decisions to Watch in Q1
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...
FDA approves first ever medication for obstructive sleep apnea — here's what that means
Tirzepatide is the active ingredient in Zepbound, the FDA approved prescription medicine for Obstructive Sleep Apnea.
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
BioPharma Dive2d
5 FDA decisions to watch in the first quarter of 2025
By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.
CBS News11d
FDA proposes new tests to detect asbestos in cosmetics and other products containing talc
a medical doctor and director of the FDA's Office of Cosmetics and Colors, said Thursday in a news release announcing the agency's action. The agency's proposed rule falls short of a ban on talc ...
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...
dermatologyadvisor2d
FDA Alert: Dermatology Drug News Roundup
FDA experts report changes in drug approvals, warnings, and indications for products for use by dermatologists and aesthetic medicine professionals.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...
news10nbc12d
Systane eye drops recalled for possible fungal contamination, FDA says
Systane brand eye drops were voluntarily recalled because of possible fungal contamination, the Food and Drug Administration ...