Tisento doses first subject in Phase IIb study of zagociguat for MELAS treatment
Tisento Therapeutics has dosed the first subject in its Phase IIb PRIZM study, examining the effects of the oral ...
FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...
Scientists announce groundbreaking single-dose treatment hope against breast cancer
TFPy, developed by researchers at University of Illinois at Urbana-Champaign in US, induces regression of tumours in multiple ...
Pharm Exec2d
Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy
Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza (nusinerse) 50 mg taken ...
Breakthrough Single-Dose Drug Wipes Out Breast Tumors in Mice Without Side Effects
A revolutionary new treatment for breast cancer has shown the ability to eliminate small breast tumors and significantly ...
A single-dose breast cancer drug to kill tumours with zero side effects
Scientists have developed a single-dose treatment for breast cancer that eliminates small tumors and significantly shrinks ...
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Biogen Inc. Announces FDA and EMA Acceptance of Higher Dose Regimen for Nusinersen in Spinal Muscular Atrophy
Biogen Inc. announced that the FDA has accepted and the EMA has validated its supplemental New Drug Application for a higher dose regimen of nusinersen, intended for treating spinal muscular ...
Pharmaceutical Technology on MSN3d
Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of spinal muscular atrophy (SMA) drug Spinraza are now under review in the US and Europe.
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FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
The higher dose regimen of nusinersen comprises a more rapid loading regimen, two 50 mg doses 14 days apart, and higher maintenance regimen, 28 mg, every 4 months, compared to the approved ...
Managed Healthcare Executive3d
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...