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GSK gets CHMP backing for Nucala in COPD and depemokimab in asthma, setting up possible Europe approvals in 2026 for IL-5 therapies.

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

NVO gains CHMP backing for a higher-dose Wegovy, paving the way for potential EU approval in 2026 as study data show stronger ...

The EMA concluded that Melatomed’s benefits outweigh its risks and supported granting marketing authorizations in Germany, Austria, Denmark, and Sweden.

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, ...

Merck MRK announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered ...

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 ...

Moderna (MRNA) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion ...

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