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GSK wins first hepatitis-B approval in Japan

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GSK’s bepirovirsen, branded Hibsago, has received its first global approval in Japan for adults with chronic hepatitis B. Japanese regulators describe it as the country’s first and only approved treatment offering a “functional cure”—sustained control without ongoing antiviral therapy. The approval was supported by the Phase III B-Well 1 and B-Well 2 trials. Among patients with lower hepatitis B surface-antigen levels, about 19% achieved a functional cure. GSK says the drug could offer a finite, roughly six-month treatment course rather than lifelong daily pills, though its precise use depends on the approved patient criteria. Bepirovirsen is an antisense oligonucleotide designed to reduce viral replication and hepatitis B surface-antigen levels while enhancing the immune response. GSK has also submitted it for review in Europe, and U.S. review has priority status; it is not yet approved in those regions. For Trodelvy, the European Commission has granted another expanded authoriz...

Roche Bets Up to $2.3 Billion on Hanmi’s Muscle-Preserving Obesity Drug

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RFK Jr. asks for public input on reshaping U.S. childhood vaccine recommendations

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FDA hold derails REGENXBIO’s planned RGX-121 refiling

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FDA Extends Capricor’s Deramiocel Decision Date to November 22

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Enhertu gains a potential first-line foothold in HER2-mutant NSCLC, but oral TKIs remain credible competitors

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Vivek Ramaswamy-backed Ambros Therapeutics to go public through Werewolf reverse merger

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EU Approves DAYBU as First Treatment for Rett Syndrome Neurobehavioral Symptoms

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Novo Nordisk Tests Lower Maintenance Doses of Oral Wegovy

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Genentech expands Oregon manufacturing while Bavarian Nordic delays Lyme vaccine trial

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Lilly teams with Amplitude on RNA vaccines

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Matwings Reports Four-Cycle Closed-Loop Protein AI Program

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Akeso advances AK157D1 B7-H3 ADC into Phase I development

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