FiercePharma2d
Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
FDA 'Closely Monitoring' Zyn Nicotine Pouches After Marketing Approval
The Food and Drug Administration (FDA) announced on Thursday that it authorized the marketing of Zyn nicotine pouches but ...
rheumatologyadvisor2d
FDA Drug Approval Decisions Expected in February 2025
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.
FiercePharma9d
Breaking down the 55 new drug approvals of 2024
A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods g | ...
The American Journal of Managed Care1d
FDA Grants 2 Traditional Approvals for Acalabrutinib
The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated ...
MedPage Today3d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...
ConsumerAffairs2d
FDA approves 20 ZYN nicotine pouches after thorough' safety review
The U.S. Food and Drug Administration (FDA) has approved 20 ZYN nicotine "pouch" products for sale after what it called "a ...
HealthDay on MSN2d
FDA Approves Omvoh for Moderately to Severely Active Crohn Disease
The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to sever ...
For first time, FDA approves marketing of nicotine pouch products
The U.S. Food and Drug Administration on Thursday okayed the marketing of 20 Zyn nicotine pouch products after undertaking an ...
Ozempic, Wegovy among drugs selected for Medicare's price negotiations
The Biden administration announced Friday that Ozempic, Wegovy and 13 additional drugs will now be covered under Medicare ...
Becker's Hospital Review3d
Watchdog flags flaws in FDA's fast-track drug approvals
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...