Novartis announced that the FDA has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of… read more.
AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) has been recommended for approval in the European Union (EU) for the maintenance treatment of asthma in patients… read more.
GSK plc announced the FDA has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung… read more.
NICE(UK): Pembrolizumab with chemoradiotherapy (external beam radiation therapy followed by brachytherapy) can be used, within its marketing authorisation, as an option for untreated International Federation of Gynecology and… read more.
According to the MHRA website, the MHRA approved Retifanlimab (Zynyz) as the first treatment given to adults with advanced Merkel cell skin cancer that has spread or returned… read more.
Novo Nordisk announced that the European Commission (EC) has granted marketing authorisation for Wegovy pill (once-daily oral semaglutide 25 mg) for the treatment of adults with obesity (BMI… read more.
Camurus announced that the FDA has accepted for review the resubmission of the New Drug Application (NDA) for CAM2029, octreotide extended-release injection, for the treatment of patients with… read more.
Pfizer Inc. announced the FDA approved Ibrance (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone… read more.
The National Institute for Health and Care Excellence (NICE) has issued thirteen Technology Appraisal decisions in June 2026, delivering nine positive recommendations, one updated recommendation, and two terminations…. read more.
Eisai Co., Ltd. announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has validated the Marketing Authorisation Application (MAA) for taletrectinib for the… read more.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a further nineteen positive recommendations spanning oncology, neurology, infectious disease, dermatology, cardiovascular medicine, diabetes,… read more.
The FDA has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications of… read more.
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