The EMA previously granted orphan designation to mavorixafor in WHIM syndrome. In April 2024, mavorixafor received U.S. Food and Drug ... approval; uncertainties inherent in the initiation and ...

has previously received FDA clearance in the United States and European CE Mark approval. Beyond Air's CEO, Steve Lisi, expressed excitement over the TGA approval, stating that shipments to ...

Biogen BIIB announced that the FDA and EMA have accepted its regulatory filings ... Per management, a higher dose regimen of the drug has the potential to slow neurodegeneration faster through greater ...

While the EMA is centralizing the approvals for each EU Member State, each has its own regulatory agency which delays post-approval commercialization. The FDA’s process is much more straightforward.

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 ...

(BIIB) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated ...

announced that the FDA has accepted and the EMA has validated its supplemental ... highlighting the uncertainties and risks associated with drug approval processes, which may lead to concerns ...

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 ...

The FDA also gave its nod to Bristol Myers Squibb’s Cobenfy (xanomeline and trospium chloride), the first new class of antischizophrenia drug to be approved in decades. Roughly one-third of last ...

The Food and Drug Administration (FDA) approved Johnson & Johnson’s ketamine-derived nasal spray to help millions of U.S. patients suffering from severe depression. Spravato, approved as a ...

The expanded use signals a promising future for ketamine and similar drugs as a mental health intervention. Spravato was first approved by the FDA in 2019, following years of research suggesting ...