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FDA approves twice-yearly shot of Gilead drug for HIV prevention

BioPharma Drive: Drug Pricing

The clearance ushers in a closely-watched launch for Gilead, which aims to show a long-acting injection can upend a market dominated by oral medicines.

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Zepbound, Mounjaro shortages are resolved, FDA confirms

BioPharma Drive: Drug Pricing

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

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FDA Allows Marketing of Vuse Tobacco-Flavored Vapes

Drugs.com

FRIDAY, July 19, 2024 -- The U.S. Food and Drug Administration on Thursday authorized the sale of the country's best-selling e-cigarette.The agency's decision only applies to several tobacco-flavored versions of the reusable product, sold as Vuse.

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First Prader-Willi drug to reduce hunger approved by FDA

BioPharma Drive: Drug Pricing

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Karst The FDA Reduction-in-Force (Termination)or RIF(T)announced last week has resulted in countless stories in the press and on personal LinkedIn accounts from those RIFd. As folks steeped in the world of generic drugs And Hatch-Waxman know, theres a lot that happens before FDA can take action on an ANDA.

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BridgeBio heart drug approved by FDA, setting up battle with Pfizer

BioPharma Drive: Drug Pricing

The approval of Attruby for transthyretin amyloidosis with cardiomyopathy begins a battle for control of a lucrative market that investors have been skeptical BridgeBio can win.

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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study. Considering FDAs new authority to specify the conditions for such confirmatory trials (e.g.,

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