A review of remote regulatory inspections has recommended that they be used in conjunction with on-site visits to enable GxP oversight post-pandemic.
List view / Grid view
Beovu® maintained best-corrected visual acuity (BCVA) and reduced central subfield thickness (CSFT) in diabetic macular edema patients.
The European Medicines Agency (EMA)’s human medicines committee (CHMP) recommends extending RoActemra's indication to include COVID-19 patients receiving systemic treatment.
The US Food and Drug Administration (FDA) issued an emergency use authorisation for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19.
Scientists found digital pill systems to be a 98 percent accurate intervention to help men adhere to pre-exposure prophylaxis (PrEP) regimens.
AstraZeneca has entered into a new global development and commercialisation agreement with Ionis Pharmaceuticals for eplontersen.
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
EMA's drug safety committee (PRAC) confirmed the risks of myocarditis and pericarditis with COVID-19 messenger RNA (mRNA) vaccines.
The development team behind Roche’s Evrysdi® (risdiplam), the first mRNA splicing modifier to be approved, have been honoured with the BPS’s Drug Discovery of the Year Award 2022.
A new microfluidics tool, the Dynamic Sampling Platform, could improve biomanufacturing of cell therapies by reducing the cost of analysing bioreactor contents.
Astellas and Dyno Therapeutics will develop adeno-associated virus (AAV) vectors for gene therapy directed to skeletal and cardiac muscle.
The European Medicines Agency (EMA)'s human medicines agency (CHMP) begins a rolling review of Valneva's COVID-19 vaccine VLA2001 following positive preliminary results.
The Medicines and Healthcare products Regulatory Agency (MHRA) approve sotrovimab for people with mild to moderate COVID-19 infection and at least one risk factor for developing severe illness.
Sanofi has entered into an agreement to acquire Origimm Biotechnology to add a potential first-in-class vaccine for acne to their pipeline.
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.