The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

FDA Grants Orphan Drug Designation to Cour Pharmaceuticals’ PBC Treatment

By Patrick Lavery

January 9th 2025

CNP-104 is a biodegradable nanoparticle that previously received fast track designation from FDA in January 2022, which would eventually make it eligible for accelerated approval and priority review.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

FDA Fast Tracks J&J’s Posdinemab for Alzheimer’s Disease

By Feliza Mirasol

January 8th 2025

This latest fast track designation marks the second such designation by FDA for J&J’s tau-directed investigational therapies for treating Alzheimer’s disease.

Japan’s MHLW Approves Takeda’s HYQVIA Subcutaneous Injection to Treat Agammaglobulinemia or Hypogammaglobulinemia

By Feliza Mirasol

January 3rd 2025

The approval makes HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] the first and only facilitated subcutaneous immunoglobulin to be approved in Japan to treat these disorders.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA Approves First Generic Version of a GLP-1 Injection for Type 2 Diabetes

By Feliza Mirasol

December 26th 2024

The approval of Hikma Pharmaceuticals’ liraglutide injection marks the first generic version of Victoza, a GLP-1 receptor agonist.

...

20 21 22 23 24

About Us

Advertise

Editorial Information

Do Not Sell My Personal Information

Terms and Conditions

Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777