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Regulatory Intelligence & Drug Approvals2 weeks agoGSK wins FDA green light for chronic hep B treatment Hibsago
GSK's antisense-based drug for chronic hepatitis B virus (HBV) infection, Hibsago, has been approved in the US, its second major market after Japan.
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA approves Cosette’s Evoxac oral solution for Sjögren’s disease
The regulatory decision represents the first new drug application (NDA) approval secured by the speciality pharmaceutical manufacturer. Cosette expects the therapy to be commercially accessible in...
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Regulatory Intelligence & Drug Approvals2 weeks agoShifting the standard: myopia companies to look out for
Medicines are under review in the clinic to treat myopia. Here are five myopia companies in sight of approval for their therapies. The post Shifting the...
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Regulatory Intelligence & Drug Approvals2 weeks agoGSK’s Jemperli gains rectal cancer approval as rivals advance across colorectal settings
BIOCENTURY | PRODUCT DEVELOPMENTGSK’S JEMPERLI GAINS RECTAL CANCER APPROVAL AS RIVALS ADVANCE ACROSS COLORECTAL SETTINGSSurgery-sparing treatment gains accelerated approval as ESMO data broaden the evidence for...
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Regulatory Intelligence & Drug Approvals2 weeks ago
FDA Approves Hibsago (bepirovirsen) for the Treatment of Chronic Hepatitis B
London, UK -- 20 October 2026 -- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for...
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
FDA today approved Hibsago (bepirovirsen) injection, in combination with existing antiviral therapy, to treat chronic hepatitis B virus (HBV) infection in certain adults without cirrhosis.
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Regulatory Intelligence & Drug Approvals2 weeks ago
Cosette Pharmaceuticals Announces FDA Approval of Evoxac (cevimeline HCl) Oral Solution
BRIDGEWATER, N.J.--(BUSINESS WIRE) October 20, 2026 --Cosette Pharmaceuticals, Inc. (“Cosette”), a U.S.-based specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has...
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA approves pralsetinib for non-small cell lung cancer with RET gene fusions
FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions
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Regulatory Intelligence & Drug Approvals2 weeks agoCompounded tirzepatide recalled after FDA warning
A compounded version of Eli Lilly's injectable weight-loss and diabetes therapy tirzepatide has been recalled from sale due to sterility concerns.
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA Approves Once-Weekly Generic Hormone Therapy Patch for Women
Today, the U.S. Food and Drug Administration approved the first generic of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), a transdermal...
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
