18 February 2025 - FDA decision expected by 18 August 2025. ...
18 February 2025 - This marks the second breakthrough therapy designation for petosemtamab in head and neck squamous cell carcinoma. ...
18 February 2025 - FDA to review applications under priority review, with a PDUFA date of 19 June 2025. ...
18 February 2025 - PDUFA target action date of 18 August 2025. ...
18 February 2025 - If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the US; ...
17 February 2025 - Second fast track designation following brain cancer approval. ...
17 February 2025 - For some medical conditions, including conditions without effective treatments, multiple promising but unproven therapies may exist, with ...
17 February 2025 - Innovent Biologics announced that its first in class PD-1/IL-2α-bias bi-specific antibody fusion protein, IBI363, has received its ...
17 February 2025 - Designation is based on TELLOMAK Phase 2 results demonstrating efficacy and a favourable safety profile in patients ...
15 February 2025 - In 2023, Teresa was diagnosed with amyotrophic lateral sclerosis. Several months later, her family started a GoFundMe ...
14 February 2025 - Most individuals in the US are concerned about prescription drug affordability. ...
14 February 2025 - On track for commercial launch in the US in the first half of 2025. ...
15 February 2025 - Samsung Bioepis’ first endocrinology biosimilar to be approved by the FDA – widening its therapeutic areas and ...
15 February 2025 - Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect ...
14 February 2025 - Agency continues efforts to increase access to insulin treatment options. ...