Laru-zova is investigational and has not been approved by FDA for use.

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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 ...

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

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, ...

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

DELRAY BEACH, Fla, Dec. 15, 2025 /PRNewswire/ -- According to MarketsandMarkets™, the Pharmaceutical Manufacturing Execution ...

Merck secures a positive CHMP opinion to expand Winrevair's PAH use, potentially broadening treatment to adult patients ...

Discover top biotech companies for 2026, featuring emerging stars and leaders set for major clinical and regulatory ...