Regulatory Authority Actions

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

FDA has revised the Emergency Use Authorization for sotrovimab.

Califf will face challenges that include COVID-19, opioids, and user fees.

EMA has recommended approval of Spikevax for children aged 6 to 11.

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.

FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.

FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.

PETA Science Consortium International e.V. and PETA scientist Jeffrey Brown share goals with new FDA Commissioner Dr. Robert Califf.

The EC approved AstraZeneca’s Saphenlo (anifrolumab) for the treatment of active autoantibody-positive systemic lupus erythematosus.

FDA has granted Eli Lilly and Company’s bebtelovimab, a monoclonal antibody designed for treatment of COVID-19, an Emergency Use Authorization (EUA).

The agency recommended 53 new active substances in 2021, up 35% from 2020.

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

Guidance published during the pandemic has been updated to include content requirements for summary safety reports.

Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.

FDA has approved sutimlimab-jome as a treatment for hemolysis in individuals with CAD.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

The draft PREVENT Pandemic Act aims to secure supply chains, expand health data collection, and support access to vital medical products

Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.

The agency discusses its response to COVID-19 and other milestones in its year-end review.

The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).

FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.