Understanding the reasoning and process of Medicare Advantage prior authorization can help you gain faster approval for a required prior authorization.

Vertex Pharmaceuticals Inc. (VRTX), a commercial-stage global biotechnology company, announced Friday a reimbursement agreement with ...

There are 20 cell and gene therapies on Europe's market versus 43 in the U.S. Find out more about this ecosystem.

First patients treated with HEMGENIX® (etranacogene dezaparvovec) gene therapy for haemophilia B in Denmark COPENHAGEN, DENMARK—21 January 2025 — CSL Behring Denmark today announced that the first ...

the conditional marketing authorisation mechanism (for medicines addressing life-threatening conditions), patients' registries and pharmacovigilance tools that allow collection of real-life data ...

The latter relates, of course, to the United States, which introduced the ESTA (Electronic System for Travel Authorization) in 2008 to allow visa-free travel, for a small fee. Since January 8 ...

The Zyn products are meant to be marketed for adults 21 or older. The FDA warned, however, that the marketing authorization does not mean that the products are safe or "FDA approved." "There is no ...

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the ...

InflaRx (IFRX) announced that the European Commission has granted marketing authorization under exceptional circumstances for Gohibic for the treatment of adult patients with SARS-CoV-2-induced ...

It received approval in the US in May 2024 through an accelerated process and in the UK in January 2025 with conditional marketing authorization. Tarlatamab is specifically indicated for adults ...

SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency ...

Filing marks company’s first Marketing Authorization Application in Europe SAN DIEGO, January 14, 2025--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the ...