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Everyday Health6h
FDA Approves New Preventive Drug for Hereditary Angioedema (HAE)
The antibody-based drug Andembry is the first to target factor XIIa, a protein responsible for swelling in people with this ...
Potential treatment for obesity-linked breathing disorder identified
Researchers from George Washington University have uncovered promising evidence in an animal study that shows setmelanotide, ...
Fierce Pharma11h
With FDA nod for HAE drug Andembry, CSL set to compete with Takeda's Takhzyro
With the FDA's approval of hereditary angioedema preventative treatment Andembry, CSL is ready to take on Takeda’s ...
The American Journal of Managed Care11h
FDA Approves Garadacimab-gxii in Hereditary Angioedema
Garadacimab-gxii is the first and only treatment that targets factor XIIa (FXIIa) for the prophylactic prevention of reditary ...
BioPharma Dive11h
FDA clears CSL’s swelling disease drug; Regeneron loses 23andMe auction
The agency cleared CSL’s hereditary angioedema drug days after “resource constraints” delayed a rival medicine. Elsewhere, ...
MedPage Today on MSN22h
FDA Approves Once-Monthly Hereditary Angioedema Drug
Anti-factor XIIa biologic garadacimab (Andembry) got the FDA greenlight for use in preventing hereditary angioedema (HAE) ...
BioPharma Dive1d
FDA to miss approval deadline for Kalvista drug due to ‘resource constraints’
A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy ...
NBC 10 Philadelphia16d
FDA grants limited approval to new Covid vaccine from Moderna
The approval, which is limited to individuals who have previously received a Covid vaccine, was granted by the FDA on Friday, according to NBC News. The newly approved vaccine, mNEXSPIKE ...
KTLA20d
SeaStar Medical Announces CMS Coverage for Medicare and Medicaid Eligible Patients with Cardiorenal Syndrome Awaiting LVAD in Investigational Trial of SCD Therapy
We have already engaged a third-party reimbursement policy expert to analyze the feasibility of obtaining reimbursement coverage upon a potential FDA approval for our SCD therapy in adult patients ...
WMBB5mon
FDA Approves Feasibility Study with SeaStar Medical’s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome
The FDA’s Center for Biologics Evaluation and Research (CBER) granted Breakthrough Device Designation for the SCD in cardiorenal syndrome with LVAD in ... regulatory approval of its SCD product ...