UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
What is compounded semaglutide? All you need to know about the weight loss drugs Hims & Hers is selling
Hims & Hers is under scrutiny for promoting compounded weight-loss drugs in a Super Bowl ad without clear FDA approval or side effect disclosures. These compounded drugs, unlike generics, are not ...
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Biocurious: Hut Hut Hut! The growing list of ASX biotechs waiting for the FDA to call the start of play
A large number of Australian biotechs are waiting for US FDA product approval – or are on the cusp of ... Read More The post ...
Superbowl Ad Sparks A Healthy Controversy About Medication Safety
The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...
Hims & Hers Super Bowl controversy: What the ad left out about its 'alternative' weight-loss drugs
The telehealth company Hims & Hers put out a Super Bowl ad that skimped on clarifying that its compounded semaglutide medications aren't FDA-approved.
The American Journal of Managed Care4d
Evolent’s Wonsettler Sees Outcomes-Based Reimbursement as “A Healthy Tool”
Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...
Mother Jones4d
The Forgotten—and Incredibly Important—History of the Abortion Pill
The Feminist Majority Foundation, they were heroic. They collected over 700,000 petitions from people across the United ...
Mastering Medicare Advantage Prior Authorization: Tips to Accelerate Your Approval
Understanding the reasoning and process of Medicare Advantage prior authorization can help you gain faster approval for a required prior authorization.
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 ...
The American Journal of Managed Care8d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
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 ...