Pharm Exec4h
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 ...
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 ...
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 ...
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 ...
Pharmaceutical Technology on MSN1d
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.
Managed Healthcare Executive1d
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 ...
Biogen Inc.: FDA and EMA Accept Applications for Higher Dose Regimen of Nusinersen in SMA
Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMA CAMBRIDGE, Mass., Jan. 2 ...
Biogen Gets U.S., European Reviews of Higher-Dose Spinraza
Biogen said the U.S. Food and Drug Administration has accepted its supplemental new-drug application, while the European Medicines Agency has validated its application, which confirms that the ...
āshibio Doses First Patient in ANDECAL study, a Phase 2/3 Trial of Andecaliximab for Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
BRISBANE, Calif., January 23, 2025--āshibio, a privately held, clinical-stage biotechnology company developing novel ...
Ionis stock rises on FDA, EMA nod for SMA drug dose increase
Investing.com -- Shares of Ionis Pharmaceuticals (NASDAQ: IONS) climbed 7% today after the company announced that regulatory agencies in the United States and Europe have accepted applications for a ...