Hosted on MSN1h
CergenX wins FDA breakthrough designation for neonatal EEG assessment tool
Trained on large databases of brain data among newborns, CergenX’s Wave device uses AI to help with earlier detection of ...
Hosted on MSN4h
Arrowhead’s plozasiran set for FDA review as Tryngolza challenge looms
An FDA approval later this year for Arrowhead’s plozasiran in FCS would put it in direct competition with Ionis’ Tryngolza.
JD Supra5h
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
Everyday Health5h
FDA Says Shortages of GLP-1 Drugs Mounjaro and Zepbound Are Over
Tirzepatide, the main ingredient in Mounjaro and Zepbound, is no longer in shortage, according to the U.S. Food and Drug Administration. Compounded copycat drugs containing tirzepatide ...
Sweeping review suggests weight-loss drugs’ effect on 175 conditions
The findings, based on an analysis of records from 2.5 million VA patients, support much of what scientists already suspected ...
The American Journal of Managed Care7h
In a First-of-Its-Kind Decision, FDA Will Allow Marketing of Nicotine Pouches
This marketing decision from the FDA covers 2 nicotine strengths, 3 mg and 6 mg, and 10 flavors of the small tobacco-free ...
JD Supra7h
FDA’s Catch-Up Plan on Cosmetics Faces Likely Regulatory Delays with Change in Administrations
The U.S. Food and Drug Administration (FDA) has been playing catch-up on three long-delayed proposed rules required under the Modernization ...
RFK Jr. wants to improve Americans’ health. Here’s some advice from the outgoing FDA chief
Robert F. Kennedy Jr. has big plans for the FDA if he's confirmed as Secretary of Health and Human Services. FDA Commissioner ...
Business Wire3d
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
Medicare to negotiate price of Ozempic, Wegovy weight-loss drugs
The Centers for Medicare and Medicaid Services (CMS) identified 15 drugs it has selected for price negotiations with drug ...
AstraZeneca Gets FDA Approval for Metastatic Breast Cancer Treatment Datroway
AstraZeneca said the U.S. Food and Drug Administration approved Datroway, a treatment for metastatic breast cancer developed in combination with Daiichi Sankyo.
Medscape3d
FDA Approves New ADC for HR+, HER2- Breast Cancer
The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with ...