Anavex had proposed restricting the drug's indication to patients with early Alzheimer's without mutations in the SIGMAR1 gene.

The third generation EGFR TKI targets EGFR mutant NSCLC, showing improved progression free survival and fewer adverse events ...

A committee has recommended an expansion of the indication for Winrevair, an approved injection therapy for adults with PAH, ...

Novo Nordisk NVO announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) ...

GSK plc GSK announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...

Moderna on Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the marketing authorization of mNexspike, a new Covid-19 vaccine. The committee's ...

NEXSPIKE is Moderna's third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and ...

As per previous communication, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had informed Anavex about a negative trend-vote following its oral examination in ...

The move broadens treatment choices for pediatric patients aged 10 years and older whose diabetes remains uncontrolled with ...

EMA issues positive opinion on Novo Nordisk's higher-dose Wegovy, supported by strong weight-loss data and ongoing reviews in ...

EMA recommends conditional authorization for ImmunityBio's Anktiva with BCG after a 71% complete response rate in ...

Novo Nordisk A/S said its high-dose version of blockbuster Wegovy has been cleared by the European Union’s drug advisory board, opening the way for use of a shot that delivers more weight loss than ...