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 ...
manilatimes19h
SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI™ is an oral, small molecule MEK inhibitor approved in the United States for the treatment of adult and pediatric ...
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 ...
GlobalData on MSN6d
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 ...
Are Natural Food Dyes Better? Experts Weigh In on the Pros and Cons
Now that the U.S. Food and Drug Administration has banned Red Dye No. 3, artificial food dyes are under increasing scrutiny.
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 ...
Stockhead on MSN8d
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 ...
Hyderabad-based Natco Pharma gets FDA approval for marketing Bosentan Tablets in the United States
Hyderabad based Natco pharma and its associate Lupin Limited got yet another US FDA approval for manufacture of Bosentan ...
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 ...
Endocrinology Advisor1d
FDA Approves Tocilizumab Biosimilar Avtozma
The FDA has approved Avtozma® (tocilizumab-anoh), a biosimilar to Actemra®, in both intravenous and subcutaneous formulations.
JD Supra4d
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 ...