Quality Systems

Participants for START Pilot Program Selected by FDA

June 29, 2024

The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.

European Commission Approves Metastatic Colorectal Cancer Monotherapy

June 27, 2024

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

FDA Drafts Guidance Document to Assist Sponsors with Diversity Action Plans

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’s Elevidys for Duchenne Muscular Dystrophy Gets Expanded FDA Approval

June 26, 2024

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

CDER Gives Update on New Drugs Regulatory Program

June 26, 2024

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.

argenx Gets FDA Nod for VYVGART Hytrulo in CIDP Indication

June 26, 2024

FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.

Reviewing the Categories of Substance Tests

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.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

June 25, 2024

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

WHO Warns About Falsified Ozempic Batches

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.

EMA Reviews Risks of CAR T-Cell Medicines and Painkillers

June 19, 2024

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.