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 ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
GlobalData on MSN3d
Supernus wins FDA approval for Parkinson’s pump on fourth try
Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of ...
FDA approved the first new kind of pain medication in 27 years. Here’s how it works
The FDA just approved a new type of pain medication, and it's a non-opioid called suzetrigine that stops body pain at its ...
Could New Government Changes Affect the Safety of Your Beauty Products?
FDA regulation of cosmetics and beauty products may change under the new administration. Here's what you need to know if that ...
Stockhead on MSN6d
Dr Boreham’s Crucible: FDA approval blasted this regenerative biotech higher in 2024… so what’s next?
Fresh from FDA approval for its paediatric stem-cell product, Mesoblast is pursuing consent for indications of heart disease ...
FDA bans Red No. 3 food dye in food, drinks: Here's what to know
The FDA announced on Wednesday that it has banned the use of Red No. 3, an additive used to give food and drinks a cherry-red ...
JD Supra2d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Is Vertex Pharmaceuticals a Buy Now That the FDA Approved Its New Pain Drug?
The U.S. Food and Drug Administration (FDA) approved suzetrigine under the brand name Journavx on Jan. 30, 2025. Journavx is a first-in-class non-opioid painkiller that acts on sodium channels in the ...
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that its manufacturing process violates safety regulations. The U.S. Food & Drug ...
Newsweek on MSN23d
FDA 'Closely Monitoring' Zyn Nicotine Pouches After Marketing Approval
Zyn is a pouch containing nicotine powder that is intended to rest in a user's mouth while the stimulant is absorbed into their bloodstream. The FDA's authorization of Zyn marks the first time ...
GlobalData on MSN4d
Femasys gains approvals for infertility and diagnostic products in Israel
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