Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking approval of Spravato (esketamine) CIII nasal spray as a monotherapy for… read more.
The biologics license application (BLA) seeking the approval of tabelecleucel (tab-cel) monotherapy for the treatment of adult and pediatric patients who are at least 2 years of age… read more.
The addition of durvalumab (Imfinzi) to gemcitabine and cisplatin demonstrated a sustained overall survival (OS) benefit vs chemotherapy alone in patients with unresectable, locally advanced or metastatic biliary… read more.
Outlook Therapeutics, Inc. announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Lytenava (bevacizumab gamma), an ophthalmic formulation of… read more.
The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils…. read more.
The European Medicines Agency (EMA) has recommended ten new products for approval at a bumper June meeting which also saw therapeutic extensions granted for eleven drugs. The watchdog’s… read more.
Vaccine manufacturers have been tasked with producing vaccines that protect against three influenza viruses, as Europe gears up for another flu season. Companies are actively producing millions of… read more.
The FDA approved Kisunla (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and Company’s Alzheimer’s treatment for adults with early symptomatic Alzheimer’s disease (AD), which… read more.
The Accelerating Clinical Trials in the EU (ACT EU) initiative has launched two advice pilots aimed at improving the quality of applications for clinical trials in Europe. The… read more.
AbbVie announced the FDA has approved Skyrizi (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate… read more.
Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Vabysmo (faricimab) marketing… read more.
GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Omjjara (momelotinib) for the treatment of myelofibrosis. Omjjara is a once-a-day, oral JAK1/JAK2 and… read more.
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