Page 46 - Priority Review News Today

PYC is a clinical-stage biotechnology company developing a pipeline of first-in-class precision medicines for patients who have genetic diseases and no...

/PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted...

The biotech company is looking to forge a path to profitability by scaling up the commercial uptake of Zynteglo and winning the FDA’s approval for its lovo-cel gene therapy for sickle cell disease.

Daiichi Sankyo today announced that VANFLYTA® is now available by prescription in the U.S. VANFLYTA is the first and only FLT3 inhibitor to be approved by the U.S. Food and Drug Administration ...

• VYJUVEK™ approved in the U.S. as the first and only topical redosable gene therapy for the treatment of dystrophic epidermolysis bullosa • 121 Patient Start Forms in the first six weeks of...

-FDA accepted Biologics License Applications (BLAs) for exagamglogene autotemcel (exa-cel) for severe Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT); Priority Review for SCD and Standard Review for TDT- -PDUFA target action date of December 8, 2023, for SCD and March 30, 2024, for TDT- -Enrollment and dosing ongoing for CTX110®, targeting CD19+ B-cell malignancies, and CTX130™, targeting CD70 for the treatment of T cell lymphomas- -Enrollment ongoing and d...

SILVER SPRING, Md., Aug. 4, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults.

/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression...

Seeking approval for Staphylococcus aureus bacteremia , acute bacterial skin and skin structure infections , and community-acquired bacterial pneumonia NDA eligible for Priority Review Ad hoc...

RUCONEST® business performed strongly in 2Q 2023; continue to anticipate low single digit annual revenue growth Strong start to U.S. Joenja® launch during 2Q...