Hosted on MSN33m
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.
Hosted on MSN1h
AstraZeneca Secures FDA Nod for New ADC Drug Datroway in Breast Cancer
AstraZeneca AZN announced that the FDA has approved its antibody-drug conjugate (ADC), datopotamab deruxtecan (or Dato-DXd), ...
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 ...
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 ...
Sweeping review suggests effect of weight-loss drugs on 175 conditions
The findings, based on an analysis of records from 2.5 million VA patients, support much of what scientists already suspected ...
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 Wire2d
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.
Medscape2d
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 ...
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 ...
The National Law Review3d
FDA Revokes Authorization for the Use of Red Dye No. 3 in Food and Ingestible Drugs
On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization ...