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 ...
Supreme Court backs FDA’s denials of flavored vaping products for now
The Supreme Court on Wednesday backed a series of decisions by the US Food and Drug Administration to deny market access for ...
US Supreme Court largely backs FDA's denial of flavored vape product applications
The U.S. Supreme Court on Wednesday largely backed the U.S. Food and Drug Administration's refusal to let two e-cigarette ...
Winners and wishers: 9 potential Bay Area drug approvals coming this year
Three other Bay Area companies — Mirum Therapeutics Inc. (Nasdaq: MIRM), Soleno Therapeutics Inc. (Nasdaq: SLNO) and Exelixis ...
US Supreme Court tosses ruling faulting FDA for denying flavored vape products
The U.S. Supreme Court threw out on Wednesday a judicial decision that found the U.S. Food and Drug Administration acted ...
Columbus Dispatch7d
Viagra was approved by the FDA 27 years ago. It changed how we talk about sex.
Thursday marks 27 years since the U.S. Food and Drug Administration approved the sale of Viagra ... “It helped create the ...
Unanimous Supreme Court upholds FDA block of flavored vapes
The Supreme Court backed the FDA's refusal to authorize the sale of kid-friendly flavored vapes, including the flavors ...
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 ...
Stockhead on MSN1h
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 ...
Orthocell wins US FDA approval for flagship nerve repair product Remplir
WA biotech Orthocell has received US Food and Drug Administration clearance for its flagship nerve repair product.
MPR10h
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.
F.D.A. 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 advance generic drug approvals were also dismissed.