GSK makes new drug submission for depemokimab in Canada
GSK has made a new drug submission (NDS) to Health Canada for the monoclonal antibody, depemokimab, targeting two specific conditions. The …
GSK has made a new drug submission (NDS) to Health Canada for the monoclonal antibody, depemokimab, targeting two specific conditions. The …
With the 78th World Health Assembly ending today, all eyes have been on this year’s World Health Organization (WHO) member’s …
Lupin has signed a licence and supply agreement with SteinCares to commercialise its biosimilar ranibizumab in Latin American markets, excluding …
The US Food and Drug Administration (FDA) has accepted Otsuka Pharmaceutical’s biologics licence application for sibeprenlimab for review. The monoclonal …
Upperton Pharma Solutions (Upperton), a contract development and manufacturing organization (CDMO) based in the UK, won the Business Expansion award …
The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) submitted by Soleno Therapeutics for diazoxide choline prolonged-release …
The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation approval to Abbisko …
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of GSK’s Blenrep …
Genentech (San Francisco, CA) has announced an investment exceeding $700m to establish its first East Coast manufacturing facility in Holly …
Roche’s blockbuster vision for phosphoinositide 3-kinase (PI3K inhibitor) Itovebi (inavolisib) has been dealt a boost after the drug demonstrated further …
The UK's National Institute for Health and Care Excellence (NICE) has issued final draft guidance endorsing the use of CSL …
The obesity therapeutics market has gone from a standing start to the story of the year in biopharmaceuticals - and …
The Trump administration’s budget reconciliation bill has passed the US House of Representatives by a wafer-thin single-vote majority. Passing the House …
Bayer’s retinal disease treatment Eylea (aflibercept) is set for an extended treatment interval, a label extension that could give the …
GSK has gained approval from the US Food and Drug Administration (FDA) for its monoclonal antibody, Nucala (mepolizumab), as an …