Regulatory Oversight and Compliance

AstraZeneca Lung Cancer Treatment Approved in China

June 27, 2024

Results of a Phase III trial showed that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death associated with EGFR-mutated non-small cell lung cancer by 44%.

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.

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.

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.

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.