Healio5d
FDA approves expanded label for Iluvien
The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...
San Diego biotech gets FDA approval for EpiPen alternative for kids
Parents and pediatricians just gained one more tool to combat severe allergic reactions in young kids. San Diego-based ARS ...
ABC News7d
Compound versions of some weight loss drugs to be restricted
They are made by licensed pharmacies, but not approved or inspected by the FDA. Drug compounding is allowed when drugs are on the FDA's shortage list, or in circumstances when a patient can't take ...
Nature9d
Upcoming FDA approval decisions in Q2 2025
Upcoming market catalysts for the second quarter of 2025 include the US approval decisions for clesrovimab (MK-1654) for respiratory syncytial virus (RSV) prophylaxis, sebetralstat for hereditary ...
Monthly Prescribing Reference15d
FDA Drug Approval Decisions Expected in April 2025
The FDA is reviewing the supplemental NDA for cabozantinib ... The Company is seeking approval for acute treatment of migraine with or without aura.
FiercePharma26d
After asset purchase from Travere, Mirum's Ctexli crosses FDA finish line in rare metabolic disorder
The FDA on Friday gave the green light to Mirum’s Ctexli, also known as chenodiol, for the treatment of adults with cerebrotendinous xanthomatosis (CTX). The approval makes chenodiol—already ...
NBC Washington13d
FDA nominee sidesteps questions on abortion pill, agency layoffs and other issues
The prospect of Trump officials overturning the approval of FDA-approved medicines is a growing concern for physicians, medical researchers and drugmakers. Mifepristone was approved roughly 25 ...
Healio27d
FDA removes semaglutide from drug shortage list
“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected ...
Yahoo Finance23d
Semaglutide shortage ends as FDA sets deadline for compounders
Compounders are on alert after the US Food and Drug Administration (FDA) declared the shortage of semaglutide –the active ingredient in glucagon-like peptide 1 receptor agonist (GLP-1RA) Wegovy ...
Ars Technica21d
Pixel Watch 3 gets FDA approval to alert you if you’re dying
It noted at the time more countries would get access as regulators approved the feature, and the FDA was apparently the first to come through outside of Europe, boosting support to 15 countries.
CNN9d
RFK Jr. wants to eliminate FDA’s controversial food additive program. Here’s why that matters
Sign up for CNN’s Eat, But Better: Mediterranean Style. Our eight-part guide shows you a delicious expert-backed eating lifestyle that will boost your health for ...
pharmaphorum4d
Autolus bags FDA approval for leukaemia cell therapy
Autolus has picked up its first product approval, getting an FDA green light for Aucatzyl as a treatment for patients with aggressive blood cancer acute lymphoblastic leukaemia (ALL). The US ...