Page 29 - Priority Review News Today

The FDA has accepted for Priority Review the BLA for pz-cel (prademagene zamikeracel) for the treatment of recessive dystrophic epidermolysis bullosa.

The FDA granted an orphan drug designation for the novel drug, NT-17, to treat people with acute radiation syndrome.

/PRNewswire/ -- 23 Nov, 2023, on the second anniversary of the initial approval for olverembatinib, Ascentage Pharma hosted a ceremony in Suzhou, China,...

Earlier today, UKs Medicines and Healthcare products Regulatory Agency granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene...

The United Kingdom is the first country to approve the use of the world's first gene therapy for treating sickle cell disease and beta-thalassemia.

Astellas Pharma Inc. and Pfizer Inc. today announced that the companies received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application for small-molecule drug Xtandi (enzalutamide).

/PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that the companies...

AstraZeneca's Truqap approved in the US for HR-positive breast cancer

Astellas Pharma Inc. and Pfizer Inc. announced that the companies received an approval by the U.S. Food and Drug Administration of a supplemental New Drug Application for XTANDI® , following FDA...

The acceptance comes after results from TRANSCEND CLL 004, which is the first trial to demonstrate clinical benefit with a CAR T cell therapy in patients who were previously treated for CLL or SLL.