About AVT23 AVT23 is a monoclonal antibody and proposed biosimilar to Xolair ® (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity ...

to European Medicines Agency (EMA) expected by early 2025 Conference call and webcast today at 8:00 a.m. ET BOSTON, Nov. 13, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company ...

According to a statement from the Argentine Health Ministry, the National Administration of Medicines ... The regulatory agency approved the drug for people aged 4 and over, regardless of whether ...

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) (“KalVista”), today announced the closing of a synthetic royalty financing agreement with DRI Healthcare Trust (“DRI”) for up to $179 million, comprised ...

We are proud to have delivered the first-and-only FDA-approved treatment for patients with seizures ... growth of ZTALMY and activities required by the FDA and European Medicines Agency specific to ...

Exelixis’s Cabometyx continues to drive revenue growth, prompting a raised 2024 forecast to $2.15–$2.2 billion. Read my EXEL ...

Ahead of this, the biotech had already offloaded half of the commercialization duties for its European Medicines Agency-approved COVID-19 subunit vaccine Nuvaxovid to Sanofi in exchange for $500 ...

The drug has the same target — amyloid beta — as the approved Alzheimer's therapies ... Drug Designation by both the FDA and European Medicines Agency. About the Phase 3 study, the company ...

NICE is Britain's agency that determines the cost-effectiveness ... annually in the U.S. Lilly's drug is also under review by the European health regulators, which rejected Leqembi earlier this ...

− Type II Variation Submission Based on the Positive HELIOS-B Phase 3 Study in which Vutrisiran Significantly Reduced the Risk of Death and Cardiovascular Events Relative to Placebo – "Today ...

Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...

But eight years after its creation, Northvolt is on the verge of bankruptcy and has become a symbol of a European economy ... Expert from the Swedish Energy Agency, Greger Ledung, a specialist ...