Drug News

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FDA approves Zolgensma to treat spinal muscular atrophy .- Novartis

AveXis, a Novartis company, announced that the FDA has approved Zolgensma (onasemnogene abeparvovac-xioi), one-time dose of gene therapy , for...

Added 4 hours ago Drug news

TSolution One surgical system filed for 510(k) approval with FDA for knee replacement.- THINK Surgical

THINK Surgical has completed enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from...

Added 4 hours ago Drug news

FDA gives premarket approval to Therascreen PIK3CA Kit as companion diagnostic for breast cancer.- Qiagen

Qiagen announced the immediate launch of its Therascreen PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory...

Added 4 hours ago Drug news

FDA approves Jakafi for the treatment of steroid-refractory acute graft versus host disease. Incyte + Novartis

Incyte Corporation has announced that the FDA has approved Jakafi (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult...

Added 1 day ago Drug news

FDA approves Piqray + fulvestrant to treat hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer.- Novartis

Novartis announced the FDA has approved Piqray (alpelisib, formerly BYL 719) in combination with fulvestrant for the treatment of postmenopausal...

Added 2 days ago Drug news

Pooled phase III data with Xeljanz shows changes that could correlate with CV risk in psoriatic arthritis .- Pfizer

To investigate the CV risk factors and major adverse cardiovascular events (MACE) in patients with active Psoriatic Arthritis (PsA) receiving...

Added 2 days ago Drug news

Chiesi Farmaceutici licences Raxone for the treatment of Leber's Hereditary Optic Neuropathy worldwide except in US and Canada. Santhera Pharma

Santhera Pharmaceuticals announces that it has entered into an exclusive license agreement with Chiesi Farmaceutici, an international research-focused healthcare group...

Added 2 days ago Drug news

OPTION trial initiated to compare WATCHMAN FLX left atrial appendage closure platform to first-line oral anticoagulants

Boston Scientific Corporation has initiated the OPTION trial to compare safety and effectiveness of the next-generation WATCHMAN FLX left atrial...

Added 2 days ago Drug news

Stryker secures FDA PMA for Neuroform Atlas brain aneurysm stent system.

Stryker announced that it has secured FDA premarket approval for its Neuroform Atlas stent system intended for use in treating...

Added 2 days ago Drug news

Nektar Therapeutics announces formation of Inheris Biopharma Inc., a CNS focused company

Nektar Therapeutics announced the formation of Inheris Biopharma, Inc., a wholly-owned subsidiary of Nektar and a CNS-focused company. Inheris will...

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