US FDA approves SpringWorks' genetic disorder drug
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...
JD Supra3 小时
From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
Evolus Gets FDA Approval for Two Injectable Hyaluronic Acid Gels
Evolus said the Food and Drug Administration approved its injectable hyaluronic acid gels, known as Evolysse Form and Evolysse Smooth, in line with management expectations.
US FDA approves Evolus' anti-wrinkle gels
Evolus said on Thursday the U.S. Food and Drug Administration has approved its two new anti-wrinkle injectable gels, expanding the company's product portfolio beyond its cosmetic injection Jeuveau.
FDA approves new pain medication as an alternative to opioids: What to know about Journavx
The FDA on Thursday approved a new class of pain medication that provides an alternative to opioids. It will be sold under ...
Pharm Exec2 小时
FDA Approves Roche’s Evrysdi for Spinal Muscular Atrophy
Evrysdi is a non-invasive, disease-modifying option that can be swallowed whole or dispersed in water for patients with ...
GlobalData on MSN1 天
FDA approves Gomekli as first neurofibromatosis drug for adults
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat ...
ConsumerAffairs13 天
FDA Drug Approvals
FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective," the letter stated. The FDA isn’t criticizing dietary supplements in ...
The FDA just approved a new painkiller. Is it too good to be true?
Meet suzetrigine, a non-opioid that promises to avoid addiction risk. But some experts say it can't replace opioids ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
FDA approves new, non-opioid painkiller Journavx
The drug, shown to be almost as effective as opioids for short-term pain, is the first fundamentally new kind of painkiller ...