Merck, known as MSD outside of the United States and Canada, announced the Phase 3 KEYNOTE‑C93 trial evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, met its primary endpoint of… read more.
JCR Pharmaceuticals announced its development plan in Japan for givinostat, a treatment for Duchenne muscular dystrophy (DMD), following consultation with the Pharmaceuticals and Medical Devices Agency (PMDA). Based… read more.
Merck BioPharma K.K., the Japanese subsidiary of Merck KGaA, began participant registration for a Phase III trial evaluating the efficacy and safety of fixed-dose combinations of follitropin alfa… read more.
Royal Philips announced FDA 510(k) clearance of its next-generation reusable Philips SpO₂ clip sensor, reinforcing the company’s ongoing commitment to providing clinicians with trusted oxygen saturation measurements that… read more.
Keenova Therapeutics plc announced the publication of a new manuscript examining whether baseline penile pain influences treatment outcomes in men with Peyronie’s disease treated with Xiaflex (collagenase clostridium… read more.
10 August 2026 – Kura Oncology, Inc. announced the publication of a manuscript in Blood, the flagship journal of the American Society of Hematology, detailing the discovery and… read more.
4 August 2026 – GE HealthCare announced the introduction of the Logiq e family, featuring Logiq e Xi and Logiq e Si, two compact laptop ultrasound systems designed… read more.
Idorsia Ltd announces that the US Drug Enforcement Administration (DEA) will publish a proposed rule to reclassify dual orexin receptor antagonists (DORAs) from Schedule IV to Schedule V… read more.
7 August 2026 – Astellas Pharma Inc. confirms it has submitted a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval of… read more.
Arcutis Biotherapeutics announced that the FDA has accepted its supplemental New Drug Application (sNDA) for Zoryve (roflumilast) cream 0.05% to expand the indication for the topical treatment of… read more.
Merck announced that the FDA has accepted a supplemental Biologics License Application (sBLA) for Enflonsia (clesrovimab-cfor) to expand its indication to include prevention of respiratory syncytial virus (RSV)… read more.
Sanofi K.K. announced that today it submitted an application to Japan’s Ministry of Health, Labour and Welfare for a partial change to the marketing authorization for Dupixent as… read more.
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