Renalytix plc announces that the FDA has granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing… read more.
Biotronik announced FDA approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest innovation in cardiac rhythm management. Amvia Edge, the market’s… read more.
Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for Lytgobi (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA). The… read more.
Incyte announced positive topline results from its randomized, vehicle-controlled, pivotal Phase III TRuE-AD3 study evaluating the safety and efficacy of Opzelura (ruxolitinib cream) in children (age at least… read more.
GSK plc announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower… read more.
Shionogi announced that its Chinese license partner Eddingpharm has won regulatory approval for its thrombopoietin receptor agonist Mulpleta (lusutrombopag) in China. The drug was approved for the treatment… read more.
Astellas Pharma Inc. announced positive topline results from the Phase IIIb DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate… read more.
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer… read more.
The Japan Pharmaceutical and Medical Devices Agency (PMDA) has approved Novartis’ Luxturna (voretigene neparvovec) for the treatment of inherited retinal dystrophies (IRDs) caused by biallelic RPE65 mutations. The… read more.
GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved an updated indication for Shingrix (Recombinant Zoster Vaccine, Adjuvanted – RZV) for the… read more.
Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at four years for… read more.
-Sandoz, a global leader in generic pharmaceuticals and biosimilars, announced that the citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab-adaz) injection will be available in the United… read more.
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