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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 Supra1h
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 ...
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 Care4h
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 Supra4h
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 ...
localnewsmatters1d
Newsom committed California to making its own insulin. It’s a year behind his schedule
Gov. Gavin Newsom’s ambitious plan to produce a cheap, generic insulin for the 3.2 million Californians with diabetes is behind the schedule he announced ...
Junk food turns public villain as power shifts in Washington
The intensifying focus in Washington has triggered a new level of interest on the legal front as lawyers explore cases to ...
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.
FDA Accepts Arrowhead Pharmaceuticals' Drug Application for Genetic Disease Treatment
Arrowhead Pharmaceuticals said Friday that the Food and Drug Administration accepted the company's new drug application for its treatment of familial chylomicronemia syndrome, a severe and rare ...