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June 29, 2024
The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.
June 27, 2024
Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.
June 26, 2024
Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.
Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.
Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.
FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.
June 25, 2024
Here, Pavan Kumar Kunala from Almac Sciences runs through the different types of tests used to analyze drug substances to ensure quality and safety.
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
June 24, 2024
This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.
June 19, 2024
PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.