BioMarin's gene therapy pipeline has had setbacks, including a three-year delay in US approval of Roctavian and stalled development of PKU gene therapy BMN 307 as the Food and Drug Administration ...

Fabry Disease Clinical Trial Pipeline Major pharmaceutical companies are working to advance the pipeline space and unlock the future growth ...

Also Read: Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses An independent data monitoring committee ...

The recent FDA approvals of two treatments for molluscum contagiosum may represent a shift in how clinicians view this disease, according to a speaker at Masters of Pediatric Dermatology.In an ...

Fitusiran (ALN-AT3) is a subcutaneously administered, investigational RNAi therapeutic targeting antithrombin (AT) in ...

Languages: English That has some policy experts confused about the FDA's ability to implement efficient recalls and protect Americans from foodborne illness or public health hazards. More ...

Jan. 31, 2025 – The FDA has approved a new non-opioid oral drug for acute pain in adults. It is the first new class of non-opioid pain medicine approved in over 20 years, providing effective ...

A nasal spray that contains esketamine — a potent derivative of ketamine — can now be taken on its own to treat adults with severe depression, the FDA says. Here's what that means.

Copyright 2025 The Associated Press. All Rights Reserved. U.S. officials have approved a new type of pain drug designed to eliminate the risks of addiction and ...

Jan 30 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with certain patient monitors from Contec and Epsimed and ...

The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.

An audit released by the Inspector General of the U.S. Department of Health and Human Services, the parent organization of the Food and Drug Administration (FDA), is not a pleasant read. Let us turn ...