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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.

Journal of the American Academy of Dermatology publishes Zorvye (roflumilast) foam, 0.3% results for seborrheic dermatitis from pivotal phase III trial – Arcutis Biotherapeutics Inc

Written by | 7 Feb 2024

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.

New long-term data for Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO) – Genentech/Roche

Written by | 6 Feb 2024

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 launches first and only biosimilar for multiple sclerosis, Tyruko (natalizumab) in Germany

Written by | 5 Feb 2024

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.

FDA approves manufacturing process change resulting in reduced median turnaround time for Yescarta CAR T-cell therapy – Kite/Gilead Sciences

Written by | 4 Feb 2024

Kite, a Gilead Company announced that the FDA has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta (axicabtagene ciloleucel). With this approval, Kite’s… read more.

FDA approval for Farapulse pulsed field ablation system – Boston Scientific

Written by | 3 Feb 2024

Boston Scientific Corporation announced it has received FDA approval for the Farapulse Pulsed Field Ablation (PFA) System. The Farapulse PFA System is indicated for the isolation of pulmonary… read more.

FDA approval for Liberta RC DBS system to treat movement disorders – Abbott

Written by | 2 Feb 2024

Abbott announced that it received approval from the FDA to launch the Liberta RC DBS system, the world’s smallest rechargeable deep brain stimulation (DBS) device with remote programming,… read more.

FDA acceptance of the PMA application for TTFields therapy for non-small cell lung cancer – Novocure

Written by | 1 Feb 2024

Novocure announced that its Premarket Approval (PMA) application seeking approval for the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for the treatment of… read more.

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