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Boston Scientific Corporation announced it has received FDA approval for the latest-generation Watchman FLX Pro Left Atrial Appendage Closure device

Written by | 13 Sep 2023

Boston Scientific Corporation announced it has received approval for the latest-generation Watchman FLX Pro Left Atrial Appendage Closure (LAAC) Device. Designed to further advance the procedural performance and… read more.

Long-term follow-up data on sustained immunogenicity and safety for Gardasil 9 published in Pediatrics – Merck Inc

Written by | 12 Sep 2023

Merck Inc., known as MSD outside of the United States and Canada, announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls… read more.

MHLW (Japan) accepts for review application for Nucala to treat chronic rhinosinusitis with nasal polyps – GSK

Written by | 11 Sep 2023

GSK plc announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted for review a supplementary new drug application (sJNDA) for Nucala (mepolizumab), a monoclonal… read more.

MHRA (UK) approves Bimzelx for patients with active psoriatic arthritis and adult patients with active axial spondyloarthritis – UCB

Written by | 10 Sep 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for bimekizumab (Bimzelx, UCB) for patients with active psoriatic arthritis and adult patients with active axial… read more.

Stallergenes Greer acquires Palforzia peanut allergy treatment business from Nestle

Written by | 9 Sep 2023

Nestlé announced that is has divested Palforzia, its peanut allergy treatment business, to Stallergenes Greer, a biopharmaceutical company which specializes in the diagnosis and treatment of allergies. The… read more.

New long-term Leqvio data from ORION-8 study, presented at ESC congress, demonstrates consistent efficacy and safety beyond six years – Novartis

Written by | 8 Sep 2023

Novartis announced new long-term data from ORION-8, a Phase III open-label extension of ORION-9, ORION-10, ORION-11 and ORION-3 trials. The data demonstrated that with twice-yearly dosing (after an… read more.

Tivdak improved overall survival in patients with recurrent or metastatic cervical cancer compared with chemotherapy alone – Seagen + Genmab

Written by | 7 Sep 2023

Seagen Inc. and Genmab A/S announced that the Phase III innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line… read more.

FDA approves Tyruko, first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis – Sandoz

Written by | 6 Sep 2023

Sandoz, a global leader in generic and biosimilar medicines, announced that the FDA has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. Tyruko is approved to treat… read more.

European Commission approves Evrysdi for babies under two months old with spinal muscular atrophy (SMA) – Roche

Written by | 5 Sep 2023

Roche announced that the European Commission has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorisation to include infants with a clinical diagnosis of SMA… read more.

FDA approves Veklury to treat COVID-19 in people with mild to severe hepatic impairment with no dose adjustment – Gilead Sciences

Written by | 4 Sep 2023

Gilead Sciences, Inc. announced that the FDA approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in… read more.

EU approves Abrysvo for respiratory syncytial virus – Pfizer

Written by | 3 Sep 2023

Pfizer announced that the European Commission (EC) has granted marketing authorization for Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both… read more.

BioMarin announces first person treated commercially with Roctavian for severe hemophilia A in Europe

Written by | 2 Sep 2023

BioMarin Pharmaceutical Inc. announced that an individual in Germany with severe hemophilia A was treated with Roctavian (valoctocogene roxaparvovec-rvox), marking the first time that the gene therapy has… read more.

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