new drug application - Search News

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 · 17h

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 · 8h

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 · 18h

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 · 18h

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,

9hon 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 ...

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.

Targeted Oncology15d

FDA Clears Investigational New Drug Application for REC-4539 in SCLC

The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small cell lung cancer and other solid tumor indications.

13d

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 ...

Yahoo Finance25d

Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism

has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous ...

Monthly Prescribing Reference14h

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.

Some results have been hidden because they may be inaccessible to you

Show inaccessible results

Related topics