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CE Mark approval of Omnipod 5 integration with Abbott FreeStyle Libre 2 plus sensor – Insulet

Written by | 19 Feb 2024

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.

Positive topline results from phase II study evaluating Ampligen (rinatatolimod) for the treatment of post-COVID conditions – AIM ImmunoTech Inc

Written by | 18 Feb 2024

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.

European Commission approves Skyclarys (omaveloxolone) to treat Friedreich’s ataxia – Biogen

Written by | 17 Feb 2024

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.

Shingrix for the prevention of shingles in at-risk adults aged 18 and over is accepted for review by China National Medical Products Administration – GSK

Written by | 16 Feb 2024

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.

The FDA has approved an expanded indication of the WaveWriter SCS systems for the treatment of chronic low back and leg pain – Boston Scientific

Written by | 15 Feb 2024

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.

Arexvy is accepted under Priority Review in US for the prevention of RSV disease in adults aged 50-59 at increased risk – GSK

Written by | 14 Feb 2024

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.

Vyalev (foslevodopa/foscarbidopa solution) available for the treatment of advanced Parkinson’s disease in Canada – AbbVie

Written by | 13 Feb 2024

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.

FDA acceptance of U.S. and EU regulatory filings for neoadjuvant Opdivo (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo in resectable non-small cell lung cancer – BMS

Written by | 12 Feb 2024

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.

Mini TEE ultrasound transducer has FDA 510 (k) approval to improve cardiac care for more patients – Royal Philips

Written by | 11 Feb 2024

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.

Late-breaking data from inspIRE and admIRE clinical trials for Varipulse Platform presented at AF Symposium – Biosense Webster J&J

Written by | 10 Feb 2024

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.

Regulatory applications accepted in the U.S. and Japan for Breyanzi (lisocabtagene maraleucel) in relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma – BMS

Written by | 9 Feb 2024

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.

FDA update for supplemental NDA for Hetlioz (tasimelteon) in the treatment of insomnia – Vanda Pharma

Written by | 8 Feb 2024

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.

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