Regulatory Authority Actions

CHMP Recommends 14 Medicines for Approval at July Meeting

July 26, 2024

An additional 11 medicines were recommended for extension of therapeutic indications, while one negative opinion was issued.

FDA Issues Combination Product Application User Fee Guidance for Staff and Industry

July 24, 2024

Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which type of application process is appropriate.

EU Makes First-in-World Approval of Dupixent as Targeted Therapy for Uncontrolled COPD

July 08, 2024

Other indications for which the Sanofi treatment has been approved include atopic dermatitis, asthma, and chronic rhinosinusitis.

FDA Approves Lilly Treatment for Early Symptomatic Alzheimer’s Disease

July 03, 2024

Kisunla (donanemab-azbt) reduced amyloid plaques in Phase III study participants by 84% after 18 months.

Publisher's Note: With Age Comes Wisdom

July 03, 2024

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

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.

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%.

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.

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.

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.