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FDA to Restrict GLP-1 Ingredients in Non-Approved Compounded Drugs, Impacting Hims

FDA to Restrict GLP-1 Ingredients in Non-Approved Compounded Drugs, Impacting Hims

FDA to Restrict GLP-1 Ingredients in Non-Approved Compounded Drugs, Impacting Hims
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FDA Implements Reforms to Accelerate Cell and Gene Therapy Development

FDA Implements Reforms to Accelerate Cell and Gene Therapy Development

FDA Implements Reforms to Accelerate Cell and Gene Therapy Development
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Hims Hers Pulls Weight-Loss Pill Amid Legal Threats from Novo Nordisk

Hims Hers Pulls Weight-Loss Pill Amid Legal Threats from Novo Nordisk

Hims Hers Pulls Weight-Loss Pill Amid Legal Threats from Novo Nordisk
Reuters Reuters
FDA to restrict GLP-1 ingredients used in non‑approved compounded drugs

FDA to restrict GLP-1 ingredients used in non‑approved compounded drugs

Feb 6 (Reuters) - The U.S.
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FDA Grants Emergency Use Authorization for Ivomec to Combat New World Screwworm in Cattle

FDA Grants Emergency Use Authorization for Ivomec to Combat New World Screwworm in Cattle

The FDA has issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) 1% Injection, a preventative treatment for New World Screwworm (NWS) in cattle, developed by Boehringer Ingelheim. This decision was made due to the lack of adequate, approved alternatives. The EUA allows the use of Ivomec within 24 hours of birth, during castrations, and when wounds appear. The authorization aims to protect animal health, safeguard the food supply, and support cattle producers. The New World Screwworm poses a significant threat to livestock, particularly as it has been reported close to the U.S.-Mexico border.
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Bayer's Asundexian Shows Promise in Reducing Secondary Stroke Risk

Bayer's Asundexian Shows Promise in Reducing Secondary Stroke Risk

Bayer has released data from the OCEANIC-STROKE study, demonstrating that its oral Factor XIa inhibitor, asundexian, can significantly reduce the risk of secondary strokes in patients who have experienced an ischaemic stroke. The study involved over 12,300 participants and compared a 50 mg daily dose of asundexian to a placebo, alongside standard antiplatelet therapy. The results showed a 26% reduction in the risk of a secondary stroke without increasing major bleeding complications. These findings were presented at the International Stroke Conference in New Orleans.
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FDA Targets Compounded Weight-Loss Drugs, Impacting Hims Hers

FDA Targets Compounded Weight-Loss Drugs, Impacting Hims Hers

The U.S. Food and Drug Administration (FDA) has announced plans to restrict the use of GLP-1 ingredients in non-approved compounded weight-loss drugs, affecting companies like Hims & Hers. The FDA's action comes amid concerns over the quality and safety of these drugs, which are marketed as cheaper alternatives to authorized treatments. Hims & Hers recently introduced a $49 weight-loss pill, significantly undercutting the price of Novo Nordisk's Wegovy pill. The FDA's enforcement actions could include warning letters, court injunctions, or product seizures, with potential involvement from the Department of Justice.
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Hims Hers Disrupts Weight-Loss Drug Market with Affordable Alternative

Hims Hers Disrupts Weight-Loss Drug Market with Affordable Alternative

Hims Hers Disrupts Weight-Loss Drug Market with Affordable Alternative
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Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results

Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results

Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results
Reuters Reuters
Novo Nordisk shares rebound as FDA targets illegal drug copies

Novo Nordisk shares rebound as FDA targets illegal drug copies

By Jacob Gronholt-Pedersen COPENHAGEN, Feb 6 (Reuters) - Shares in Danish drugmaker Novo Nordisk gained 5.2% on Friday, recovering some of the previous two sessions' steep losses, after the U.S. Food and Drug Administration (FDA) pledged to address mass-marketing of unapproved drugs.
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Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results in Skin Disease

Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results in Skin Disease

Priovant Advances Brepocitinib to Phase 3 Following Positive Mid-Stage Results in Skin Disease
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FDA Issues Emergency Use Authorization for Ivermectin to Combat New World Screwworm in Cattle

FDA Issues Emergency Use Authorization for Ivermectin to Combat New World Screwworm in Cattle

The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for Ivomec (ivermectin) 1% Injection, a preventive measure against New World Screwworm (NWS) in cattle. This authorization, secured by Boehringer Ingelheim, allows the use of the product in specific situations such as within 24 hours of birth, during castration, or when a wound appears. The EUA is a response to the lack of adequate, approved alternatives for preventing NWS infestations, which pose a significant threat to cattle health. The USDA is also actively monitoring the northward spread of NWS, which has been reported close to the U.S.-Mexico border.