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Regulatory Intelligence & Drug Approvals3 weeks agoFDA approves Asahi Kasei’s Hovilpri for refractory HSV
This oral medication is indicated for patients whose infections do not respond, with or without documented resistance, to standard antiviral therapies including acyclovir, famciclovir, or valacyclovir....
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA nod for rare neurology drug
Nature Biotechnology, Published online: 12 October 2026; doi:10.1038/s41587-026-03349-0FDA nod for rare neurology drug
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Regulatory Intelligence & Drug Approvals3 weeks agoAicuris acquisition delivers new drug for Asahi Kasei
Asahi Kasei's $920m takeover of Germany's Aicuris in April has paid off with FDA approval for the herpes simplex virus drug at the heart of the...
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Regulatory Intelligence & Drug Approvals3 weeks ago
Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Granted FDA Fast Track Designation for First-Line Advanced or Metastatic Biliary Tract Cancer
Nanjing, China — October 12, 2026 — Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) today announced that the U.S. Food...
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Regulatory Intelligence & Drug Approvals3 weeks agoNew Optimal Transport Framework Reconstructs Gene Networks and Cell Fates From Single-Cell Snapshots
Researchers have developed CardamomOT, an optimal transport-based framework that jointly infers gene regulatory networks, reconstructs unobserved protein trajectories, and enables generative predictions from single-cell RNA sequencing...
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Regulatory Intelligence & Drug Approvals3 weeks ago
FDA Approves Weltruza (olanzapine) Once-Monthly Subcutaneous Injection for the Treatment of Adults with Schizophrenia
PARSIPPANY, N.J. and TEL AVIV, Israel, Oct. 09, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)...
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus
FDA has approved Hovilpri (pritelivir) tablets for adults with weakened immune systems (i.e., immunocompromised patients) who have mucocutaneous lesions caused by herpes simplex virus (HSV) infection...
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Regulatory Intelligence & Drug Approvals3 weeks agoHow COVID, Characterization, and Commerce Are Driving an RNA Revolution
COVID-19 accelerated efforts to develop faster, more efficient ways of manufacturing high-quality RNA sequences. The post How COVID, Characterization, and Commerce Are Driving an RNA Revolution...
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Regulatory Intelligence & Drug Approvals3 weeks agoPar Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter
FOR IMMEDIATE RELEASE - ROCHESTER, MI– October 8, 2026 –Par Health is voluntarily recalling two lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection,...
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Regulatory Intelligence & Drug Approvals3 weeks agoFDA review docs spark Revolution sell-off; Zealand diabetes data underwhelm analysts
The new disclosure suggested Rasonque might not be as broadly effective as previously thought. Elsewhere, Ultragenyx got a much-needed cash infusion and TCGX started a China-focused...
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
Acumen Pharmaceuticals Announces Topline Results from Phase 2 ALTITUDE-AD Clinical Trial of Sabirnetug (ACU193) for the Treatment of Early Alzheimer’s Disease; Trial Did Not Meet Primary Endpoint
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
