Regulatory
April kicks off with three FDA target action dates, including one that could potentially set the stage to move CAR-T therapies into earlier lines of treatment.
After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
Data analytics firm GlobalData expects potential FDA approvals this year of Sanofi and Regeneron’s Dupixent and Verona’s ensifentrine to transform the treatment of chronic obstructive pulmonary disease.
Global healthcare and life sciences look toward automation, AI and Quantum to protect patient data and save lives.
With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science.
AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
The regulator has allowed for emergency use of Invivyd’s monoclonal antibody Pemgarda as a COVID-19 pre-exposure prophylaxis for moderately or severely immunocompromised patients.
Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.
AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers.
PRESS RELEASES