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Regulatory Intelligence & Drug Approvals2 months 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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Regulatory Intelligence & Drug Approvals2 months agoGSK prepares frontline FDA bid for Jideytro, its first lung cancer drug
GSK is advancing its inaugural lung cancer asset, Jideytro, toward a landmark first-line FDA approval, aided by an unprecedented complete response rate.
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Regulatory Intelligence & Drug Approvals2 months agoSTAT+: Scholar Rock wins FDA approval for first drug to target SMA muscle loss
A late-stage clinical trial found that, when combined with an SMN2-targeting drug, Isembyld caused young patients’ motor skills to improve after a year.
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Regulatory Intelligence & Drug Approvals2 months ago
FDA Approves Omcazio (cabozantinib) Capsule Formulation for Administration Without Regard to Food
SAN JOSE, CA AND TAIPEI, TW / September 11, 2026 / Handa Pharmaceuticals, Inc. (“Handa” or the “Company”) (TSE:6620) announced that the U.S. Food and Drug...
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Regulatory Intelligence & Drug Approvals2 months ago
FDA Approves Isembyld (apitegromab-mstn) Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--September 11, 2026-- Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular...
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Regulatory Intelligence & Drug Approvals2 months ago
FDA Approves Pharming’s Joenja as First Treatment for Children with APDS in the U.S.
Leiden, the Netherlands, September 11, 2026: Pharming (Euronext Amsterdam: PHARM/Nasdaq: PHAR), a global biotechnology company focused on rare immune and genetic diseases, today announced that the...
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Regulatory Intelligence & Drug Approvals2 months agoNotable Approvals | Drugs
News about human drug-related approvals
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Regulatory Intelligence & Drug Approvals2 months 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 Approvals2 months 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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Regulatory Intelligence & Drug Approvals2 months 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....
LncRNA SBF2-AS1 Worsens Heart Injury After Attack via miR-149-5p/PHLPP2 Axis
Stigmatizing language found in over half of primary care patient records
Research report: The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
