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Regulatory Intelligence & Drug Approvals3 weeks agoFDA Expands Anktiva Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease
CULVER CITY, Calif., October 14, 2026 — ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has...
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Regulatory Intelligence & Drug Approvals3 weeks ago
Legacy Healthcare’s Cinainu Receives FDA Breakthrough Therapy Designation for Alopecia Areata in Adults, Adolescents and Children Aged 2 Years and Older
EPALINGES, Switzerland, Oct. 13, 2026 /PRNewswire/ -- Legacy Healthcare, a biopharmaceutical company developing innovative botanical prescription drugs, today announced that the U.S. Food and Drug Administration...
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Regulatory Intelligence & Drug Approvals3 weeks agoX-Chromosome Gene Linked to Increased Autism Diagnosis in Males
New research suggests that variants in the MECP2 gene on the X chromosome might help partly explain why autism is diagnosed about four times more often...
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Regulatory Intelligence & Drug Approvals3 weeks agoSTAT+: Many patient, consumer reps on FDA advisory panels have ties to groups funded by pharma, analysis finds
Nearly 40% of FDA advisory committee meetings over a 20-year period included either a patient or consumer rep with active ties to an advocacy group funded...
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Regulatory Intelligence & Drug Approvals3 weeks agoSilgan Dispensing Systems – 734538 – 10/05/2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
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Regulatory Intelligence & Drug Approvals3 weeks agoSyndax ends fibrosis program for Niktimvo after mid-stage disappointment
Syndax Pharmaceuticals will no longer test Niktimvo for idiopathic pulmonary fibrosis, but the company’s work to expand the drug’s label in chronic graft-versus-host disease, for which...
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Regulatory Intelligence & Drug Approvals3 weeks agoConvenience Kit Recall: Medline Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
Certain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
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Regulatory Intelligence & Drug Approvals3 weeks agoOverton confirmation battling clock, abortion politics
BIOCENTURY | POLITICS, POLICY & LAWOVERTON CONFIRMATION BATTLING CLOCK, ABORTION POLITICSSen. Hawley’s concerns about FDA study of mifepristone safety add complexity to tight confirmation window
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Regulatory Intelligence & Drug Approvals3 weeks ago
FDA Approves Hovilpri (pritelivir) for the Treatment of Mucocutaneous Herpes Simplex Virus (HSV) Lesions
Tokyo – October 10, 2026 – Asahi Kasei Therapeutics, Inc., the global specialty pharmaceutical business of Tokyo-based Asahi Kasei, with U.S. and European business headquarters in...
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Regulatory Intelligence & Drug Approvals3 weeks agoRevMed’s Rasonque gets a subtype data asterisk, but analysts remain bullish
Data released by the FDA show that Revolution Medicine’s newly approved pancreatic cancer drug underperformed in a large subgroup of patients, but analysts say the biotech...
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
