MPR9h
FDA Drug Approval Decisions Expected in May 2025
The FDA is expected to decide on treatments for COPD, psoriasis, rare neuroendocrine tumors, and a next-generation COVID-19 vaccine.
Healthline18h
FDA Authorizes First At-Home Test for Chlamydia, Gonorrhea: What to Know
The FDA has approved a new at-home test for common sexually transmitted infections and diseases. The test for chlamydia, ...
Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
FDA layoffs could raise drug costs and erode food safety
Trump cutbacks were supposedly aimed at administrators. But scientists in food and drug-testing labs and policy experts who ...
Stockhead on MSN23h
Level achieved: Orthocell gains FDA approval for flagship nerve repair product
Orthocell receives US FDA 510(k) approval for Remplir, its flagship nerve repair product and can now start commercial ...
MPR1d
Vanrafia Gets Accelerated Approval for Immunoglobulin A Nephropathy
The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ® (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid ...
T-Cell Acute Lymphoblastic Leukemia Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
In March 2025, Juventas Cell Therapy Ltd. conducted a phase Ib/II trial to evaluate the safety and efficacy of CNCT19 ...
Regenerative medicine firm Vivex Biologics navigates complex FDA approval landscape
Vivex Biologics chairman John McCallum breaks down the challenges, costs, and strategies behind bringing medical innovations ...