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Regulatory Intelligence & Drug Approvals2 days agoCentric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels
FOR IMMEDIATE RELEASE – 9/9/2026 – Houston, Texas, Centric Compounding is voluntarily recalling 6 lots of Glutathione 200mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable vials to...
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Drug Discovery & Therapeutics3 days agoConsiderations for Potential Future Therapeutic Use of Psychedelic Drugs Public Hearing – 09/14/2026
The Food and Drug Administration is announcing a public hearing on the potential future therapeutic use of psychedelic drugs.
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Regulatory Intelligence & Drug Approvals3 days agoNotable Approvals | Drugs
News about human drug-related approvals
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Regulatory Intelligence & Drug Approvals3 days agoFDA Approves First Therapy to Target Muscle Loss in Spinal Muscular Atrophy
The U.S. Food and Drug Administration today approved Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy (SMA) in adults and pediatric patients 2 years of age...
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Regulatory Intelligence & Drug Approvals3 days agoAdvancing Generic Drug Development: Modernizing Bioequivalence Approaches for Topical & Transdermal Products – 09/10/2026
This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products.
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Capital, M&A & Industry Strategy3 days agoEco-NAMs Webinar Series | QSARs to Predict Aquatic Toxicity – 09/17/2026
The Eco-NAMs Webinar Series aims to present the most informative and up-to-date science on new approach methodologies (NAMs) for ecotoxicity assessments
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Regulatory Intelligence & Drug Approvals3 days agoFDA approves first treatment for children aged 4-11 years with APDS, a rare genetic disorder of the immune system
FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome in children 4-11 years who weigh at least 27 kg....
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Regulatory Intelligence & Drug Approvals4 days agoTips to Stay Safe in the Sun: From Sunscreen to Sunglasses
Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. The FDA continues to...
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Regulatory Intelligence & Drug Approvals4 days agoShould You Put Sunscreen on Infants? Not Usually
Your infant’s sensitive skin is vulnerable to serious burns. But sunscreen isn’t the answer. Infants are at greater risk than adults of sunscreen side effects, such...
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Regulatory Intelligence & Drug Approvals4 days agoFDA Rare Disease Innovation Hub
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of...
Psychedelic therapies ride wave of public favor into FDA hearing
After a brief storm of political headwinds, mRNA is back with strong momentum
STAT+: Trump’s secretive pharma deals may undermine ‘most-favored nation’ pricing, an analysis suggests
Scientists turn pig semen extract into eye drops that kill cancer in mice
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
