资讯

Managed Healthcare Executive1 天
FDA Approves Uplizna for Chronic Inflammatory Condition IgG4-RD
Uplizna is the first approved treatment for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition ...
How another firm's FDA approval could mean a big win for Denali Therapeutics
Key to 400-employee Denali's submission is the FDA allowing measurement of a type of GAG, called heparan sulfate, in ...
Oncology Nursing News7 天
Oncology Drugs Approved by the FDA in March 2025
The FDA approved several therapies in oncology in the month of March 2025. These drugs included treatments for ...
Medical Device Network on MSN4 天
‘Fear and uncertainty’ linger over FDA’s future in wake of Trump admin’s layoffs
During a webinar hosted by NAMSA, experts reflected on what US health agency job cuts could mean for device approvals and ...
Medscape4 天
FDA Approves First and Only Therapy for IgG4-RD
Inebilizumab-cdon was previously approved by the FDA for neuromyelitis optica spectrum disorder (NMOSD) in adults who are ...
The American Journal of Managed Care5 天
Inebilizumab FDA Approved as First Treatment for IgG4-RD
Inebilizumab-cdon (Uplizna; Amgen) was approved as the first and only treatment for immunoglobulin G4–related disease ...
CURE6 天
FDA Approves Initiation of a New Trial in Recurrent Glioblastoma
The FDA has approved an application to initiate a pilot study with Alpha DaRT for patients with recurrent glioblastoma, a ...
CURE4 天
FDA Grants Rare Pediatric Designation to Treatment With NEO100 in Brain Cancer
The FDA has granted Rare Pediatric Disease Designation for NEO100 in the treatment of pediatric-type diffuse high-grade ...
CNN6 天
FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The Wall Street Journal first reported that the FDA had missed its decision deadline. The move came as the FDA named Dr. Scott Steele acting director of the Center for Biologics Evaluation and ...
PharmExec8 天
FDA Approves Sanofi’s Qfitlia for Prophylaxis in Patients with Hemophilia A or B
Qfitlia is the first FDA-approved antithrombin-lowering therapy indicated for routine prophylaxis to prevent or reduce ...