Regulatory Authority Actions

The UK MHRA has expanded the use of Cosentyx for use in pediatric arthritic conditions.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA keeps its user fees but fails to gain important reforms.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.

FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.

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.