Regulatory Authority Actions

FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.

Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.

The European Union publishes long-awaited changes to Annex 1.

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.

The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.

The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.

Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.

Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.

Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.

FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.

Democrats approve curbs for Medicare plans, but not for commercial drug coverage.

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.

The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.

The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.

A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.

Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.

Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.