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510(k) clearance from the FDA for the Medrad Centargo CT injection system – Bayer

Written by | 12 Nov 2024

Bayer announced  510(k) clearance from the FDA for its Medrad  Centargo CT Injection System, an innovative multi-patient injector that drives workflow efficiency with design features that integrate with… read more.

First clinical outcomes associated with the Shockwave Javelin Peripheral IVL Catheter – Shockwave Medical / J&J MedTech

Written by | 11 Nov 2024

Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced  the first clinical outcomes associated with the Shockwave… read more.

Positive results from Study 304 for lumateperone for prevention of relapse in patients with schizophrenia – Intra-Cellular Therapies

Written by | 10 Nov 2024

Intra-Cellular Therapies, Inc. announced positive results from Study 304 evaluating the efficacy and safety of lumateperone 42 mg for the prevention of relapse in adult patients with schizophrenia…. read more.

The EMA has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one – Sanofi

Written by | 9 Nov 2024

The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged… read more.

NICE (UK) recommends danicopan as add on to ravulizumab or eculizumab to treat residual haemolytic anaemia – AstraZeneca

Written by | 8 Nov 2024

NICE (UK): Danicopan (Voydeya) from Alexion/AstraZeneca, is recommended, as an add-on to ravulizumab or eculizumab as an option for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults who have… read more.

Lundbeck announces positive results from phase III pivotal trial (SUNRISE) of Vyepti (eptinezumab) in migraine prevention

Written by | 7 Nov 2024

Lundbeck announced that Vyepti (eptinezumab) met the primary and all key secondary endpoints in SUNRISE, a phase III pivotal trial predominantly conducted in Asia evaluating the efficacy and… read more.

European Commission approves expanded use of HIV-1 therapy Edurant (rilpivirine) in younger pediatric patients – Johnson & Johnson

Written by | 6 Nov 2024

Johnson & Johnson announced that the European Commission (EC) has approved Edurant (rilpivirine) for the treatment of HIV-1 infection in adults and children weighing at least 25 kg… read more.

TRISCEND II trial demonstrates superior clinical and quality-of-life benefits with Edwards EVOQUE system for severe tricuspid regurgitation

Written by | 5 Nov 2024

Edwards Lifesciences Corporation  announced that the EVOQUE system demonstrated superiority compared to medical therapy alone for the one-year primary endpoint of the TRISCEND II trial. TRISCEND II is… read more.

FDA approves Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections – Iterum Therapeutics

Written by | 4 Nov 2024

Iterum Therapeutics plc  announced that the FDA  has approved Iterum’s new drug application for Orlynvah (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs)… read more.

New SPECTREM study findings reveal Tremfya (guselkumab) effectively clears overlooked and undertreated plaque psoriasis – Johnson & Johnson

Written by | 3 Nov 2024

Johnson & Johnson announced that treatment with Tremfya (guselkumab) resulted in clear or almost clear skin in the majority of adults with low body surface area (BSA) moderate… read more.

Sage Therapeutics announces a strategic reorganisation

Written by | 2 Nov 2024

Sage Therapeutics, Inc. announced a strategic reorganization of its business operations to support the ongoing launch of Zurzuvae in postpartum depression and focus pipeline development efforts ahead of… read more.

FDA approves Botox Cosmetic (onabotulinumtoxinA) for temporary improvement in platysma bands in adults – Allergan/AbbVie

Written by | 1 Nov 2024

Allergan Aesthetics, an AbbVie company announced the FDA approval of Botox Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and… read more.

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