Regulatory Authority Actions

CBER maps modernization plan to handle surge in research and applications.

The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.

FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.

FDA is highlighting how the Patient-Focused Drug Development program has encouraged active involvement of many patient groups in bringing their perspectives into the process of developing, testing, and approving new medicines.

EC has approved Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss.

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.

Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.

Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.

EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.

Looking back at the biologics and large molecule drugs approved by FDA in the past year can give us hints toward what will be approved in the future.

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

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.