FDA

Pfizer and BioNTech have submitted data supporting the vaccination of children 5 to 12 years of age with Comirnaty (Covid-19 mRNA vaccine) to the European Medicines Agency (EMA) for a variation of the Conditional Marketing Authorization (CMA) in the European Union (EU). According to The New York Times, federal regulators evaluated the safety and efficacy of this vaccine, […]

BridgeBio has been granted Fast Track designation United States Food and Drug Administration (FDA) for the investigation of BBP-418 as a treatment option for Limb-girdle Muscular Dystrophy Type 2i (LGMD2i). This is the fifth Fast Track designation for an investigational therapy that BridgeBio has received in 2021.  BridgeBio’s LGMD2i investigational therapy is one of the company’s 14 programs that […]

An in vitro study of drugs already approved by the US Food and Drug Administration (FDA) to treat a range of conditions has shown eight of them are also effective in slowing SARS-CoV-2 replication in infected human cells. The team led by University of Manchester scientists used the drugs to treat liver and kidney cells, […]

Versantis’ lead product candidate VS-01 has been has granted orphan drug designation (ODD) by the Food and Drug Administration (FDA) for the treatment of hyperammonemia (HA) in inborn errors of metabolism (IEM).   “This orphan drug designation from the FDA validates the scientific rationale of VS-01 in a new indication encompassing multiple genetic disorders where there […]

Moderna has initiated its submission to the US Food and Drug Administration (FDA) for the evaluation of a booster dose of the Moderna Covid-19 vaccine (mRNA-1273) at the 50 µg dose level. The company expects to submit data to the European Medicines Agency (EMA) and other regulatory authorities around the world shortly.  “We are pleased to initiate […]

News round-up by DDW’s Megan Thomas for 23-27 August  The Covid-19 pandemic has undoubtedly put virology back on the drug discovery map and this week, DDW’s Megan Thomas has rounded up five stories which show updates and advancements in the fight against the virus.   1. Moderna’s Covid-19 vaccine maintains antibodies against variants  New data has […]

Moderna has completed the rolling submission process for its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the full licensure of the its Covid-19 vaccine for active immunisation to prevent Covid-19 in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested Priority Review designation.   “This BLA submission for our Covid-19 vaccine, […]

The US Food and Drug Administration (FDA) has approved the Biologics License Application for the Pfizer-BioNTech Covid-19 vaccine. It will now be marketed as Comirnaty for the prevention of Covid-19 disease in individuals 16 years of age and older.  It is the first COVID-19 vaccine to be granted approval by the FDA.  The vaccine continues to be available under emergency use authorisation (EUA), including for individuals […]

The US Food and Drug Administration (FDA) has approved Biogen’s regulatory application for the use of aducanumab in the treatment of Alzheimer’s disease, which removes amyloid from brains. Aducanumab is the first new Alzheimer’s drug in nearly 20 years, and there is reportedly mixed evidence over its efficacy. However, according to expert commentary, the “desperate […]

GammaDelta Therapeutics’ Investigational New Drug (IND) application has been cleared by the US Food and Drug Administration (FDA) for its allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy, GDX012, to be investigated as a treatment for haematological malignancies. The FDA also granted orphan drug designation to allogeneic Vδ1 γδ T cell therapy (GDX012) […]