The FDA has accepted a biologics license application (BLA) for Alvotech’s ustekinumab biosimilar candidate (AVT 04) referencing Stelara, which will be used to treat several autoimmune disorders. Alvotech… read more.
Roche announced that the FDA has approved Xolair (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods… read more.
Insulet Corporation ,the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced it has received CE mark approval under the European Medical Device… read more.
AIM ImmunoTech Inc. announced positive topline results from the Company’s Phase II study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the… read more.
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.
Bristol Myers Squibb announced two regulatory acceptances for applications for; i. neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and ii. adjuvant Opdivo for the perioperative treatment of… 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.
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