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FDA and EMA review Biogen's higher dose SMA drug

CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, has reached a pivotal phase as regulatory agencies in the United States and Europe are now reviewing a higher dose regimen of nusinersen,

Business Insider · 20h

Biogen announces FDA, EMA accepted applications for higher dose of nusinersen

Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has accepted the company’s supplemental New Drug Application, sNDA,

Managed Healthcare Executive · 11h

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 FDA-approved dosage.

Stockhouse · 20h

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 . C

MarketWatch · 20h

Biogen Gets U.S., European Reviews of Higher-Dose Spinraza

Biogen said U.S. and European regulators will review its applications seeking approval of a higher-dose regimen of its Spinraza drug for the neuromuscular disease spinal muscular atrophy. The Cambridge,

11hon MSN

Ionis stock rises on FDA, EMA nod for SMA drug dose increase

Shares of Ionis Pharmaceuticals (NASDAQ:IONS) climbed 7% today after the company announced that regulatory agencies in the ...

Business Wire6d

Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

Atara's New Drug Applications Placed on Hold by FDA

Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...

JD Supra6d

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use

The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...

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New drug development tool could revolutionize industry

A University of Oklahoma professor and his team have discovered a new way to put atoms into drug molecules that could revolutionize the drug industry. The safer, cheaper, more environmentally friendly ...

ophthalmologytimes12d

FDA accepts revised supplemental New Drug Application for IZERVAY

The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.

cidrap.umn6d

BARDA to fund development of COVID preventive drug

Shionogi will receive $375 million to develop a long-acting protease inhibitor designed to prevent SARS-CoV-2 infection in ...

Healio8d

FDA clears investigational new drug application for lorundrostat in OSA, hypertension

The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...

Monthly Prescribing Reference16h

FDA Extends Review of Elamipretide for Barth Syndrome

The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.

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