Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
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 ...
JD Supra1d
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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
The American Journal of Managed Care11d
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 ...
The American Journal of Managed Care6d
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 ...
OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
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 ...
Is Vertex Pharmaceuticals a Buy Now That the FDA Approved Its New Pain Drug?
Lately, one of America's leading pharmaceutical companies can't catch a break from Wall Street. Shares of Vertex ...
Stock Market Sleeps On Stereotaxis MAGiC CE Mark
Stereotaxis gains CE Mark for MAGiC catheter, boosting revenue with high margins. FDA approval expected soon. Click here to ...
FDA Accepts Integral Molecular's Membrane Proteome Array™ Qualification Plan, Advancing the Platform for Approval as a Drug Development Tool
Integral Molecular, a leader in antibody discovery technologies, is proud to announce that the FDA has accepted their ...
FiercePharma2d
Amid takeover talk, SpringWorks scores FDA nod for rare genetic disease treatment Gomekli
Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
Acsh.org3d
Rare Diseases Are Neglected. The FDA Needs A Dedicated 'Center of Excellence for Rare Diseases'.
The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...