Regulatory Filings and Submissions

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.

ADC development is on a positive trajectory from a deeper understanding of therapeutic mechanisms and technological advances.

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

Genentech’s Susvimo (ranibizumab injection) is approved for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration.

EMA’s CHMP concluded that a booster dose of Moderna’s Spikevax vaccine may be considered in people aged 18 and older.

FDA has worked to clarify how drug development can gain from tapping into information in health care systems and claims databases.

EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.

Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.

Roche has submitted a marketing authorization application to EMA for Ronapreve (casirivimab/imdevimab) as a treatment for COVID-19.

EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.

FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.