Biogen Inc. announced the European Commission (EC) has authorized Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older …. read more.
GSK plc announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted for review the regulatory application of Shingrix (Recombinant… read more.
Boston Scientific Corporation announced that the FDA has approved an expanded indication of the WaveWriter SCS Systems for the treatment of chronic low back and leg pain in… read more.
GSK plc announced that the FDA has accepted under priority review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged… read more.
AbbVie has announced that Vyalev (foslevodopa/foscarbidopa solution) is now available for the treatment of motor fluctuations in patients with advanced levodopa-responsive Parkinson’s disease who do not have satisfactory… read more.
Royal Philips a global leader in health technology, announced that its latest TEE transducer, designed to serve more patients with improved overall comfort, has received FDA 510(k) clearance…. read more.
Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced 12-month results from the company-sponsored inspIRE study , “Predictors of… read more.
Bristol Myers Squibb announced three regulatory acceptances from the FDA and Japan’s Ministry of Health, Labour and Welfare (MHLW) for Breyanzi (lisocabtagene maraleucel) In the U.S., the FDA… read more.
Vanda Pharmaceuticals Inc. announced that on February 4, 2024, it received a notification from the FDA stating that as part of its ongoing review of Vanda’s supplemental New… read more.
Arcutis Biotherapeutics, Inc. announced that the Journal of American Academy of Dermatology (JAAD) published positive results from the pivotal Phase III STRATUM trial evaluating Zoryve (roflumilast) foam, 0.3%… read more.
Genentech, a member of the Roche Group announced new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo (faricimab-svoa) in macular edema due to… read more.
Sandoz announces the launch of Tyruko (natalizumab) in Germany from February Developed by Polpharma Biologics, Tyruko is the first and only biosimilar to treat RRMS.(r/r Multiple Sclerosis). Tyruko… read more.
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