Regulatory Oversight and Compliance

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.

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.

AstraZeneca mAb Approved by FDA for Endometrial Cancer Patients

June 20, 2024

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

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.

CDER Announces Emerging Drug Safety Technology Meeting Program

June 10, 2024

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

Drug Shortage Reports Emphasize Continuing Problems

June 10, 2024

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

Using RWD in Non-Interventional Studies

June 05, 2024

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.