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 ...
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 ...
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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.
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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.
US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
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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 ...