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Regulatory Intelligence & Drug Approvals1 month agoMerck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal
Daiichi Sankyo and Merck & Co. have withdrawn an antibody-drug conjugate (ADC) filing after the FDA said they lacked the data for accelerated approval in a...
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Regulatory Intelligence & Drug Approvals1 month agoApproved Metabolism Drugs Rescue Disease Signs in SMA Mice
Spinal muscular atrophy has long been understood as a disease of motor neurons, a genetic condition in which the progressive loss of nerve cells that control...
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Regulatory Intelligence & Drug Approvals1 month agoIgA nephropathy’s formula for continuous innovation
BIOCENTURY | PRODUCT DEVELOPMENTIGA NEPHROPATHY’S FORMULA FOR CONTINUOUS INNOVATIONSeven drugs have been approved for IgAN, but development continues for best-in-class products
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Regulatory Intelligence & Drug Approvals1 month agoIfinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Voluntarily Withdrawn
Tokyo – (September 25, 2026) – The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK),...
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Regulatory Intelligence & Drug Approvals1 month ago
FDA Approves Gazyva for Idiopathic Nephrotic Syndrome in Patients Aged 2 and Older
South San Francisco, CA — September 25th, 2026 — Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and...
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Regulatory Intelligence & Drug Approvals1 month ago
FDA Approves Lilly’s Olumiant (baricitinib) for Pediatric Patients 12 Years of Age and Older with Severe Alopecia Areata
INDIANAPOLIS, Sept. 25, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib), a...
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Regulatory Intelligence & Drug Approvals1 month agoFDA Approves Third Treatment for Fibrodysplasia Ossificans Progressiva
FDA has approved Atebrioz (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia...
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Regulatory Intelligence & Drug Approvals1 month agoFDA Approves Drug to Treat Idiopathic Nephrotic Syndrome in Patients 2 Years and Older
FDA has approved Gazyva (obinutuzumab) injection to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing...
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Lilly wins approval for once-weekly insulin shot
The FDA approved Eli Lilly’s Onswik, a once-weekly basal insulin for adults with type 2 diabetes, offering patients an alternative to daily long-acting insulin injections.
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Regulatory Intelligence & Drug Approvals1 month agoSTAT+: Pharmalittle: We’re reading about a reticent FDA commish nominee, a Novo deal, and more
President Trump’s nominee to lead the FDA was grilled by senators on hot button topics like China, vaccines, and abortion access
Opentrons Raises $40M in Series E to Expand Its Robotics, Software, Data Infrastructure
100 Million-Cell AI-Ready Dataset with Single-Cell and Proteomic Data Created by Parse and Nomic
No Nonsense: David Liu Lauds Progress in Disease-Agnostic Gene Editing at ESGCT
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
