Page 10 - Priority Review News Today

PRISM MarketView Highlights Work of Emerging Companies on Rare Disease Day...

The sBLA is supported by data from the phase 3 NRG-GY018 trial, which included patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either pMMR or dMMR.

Biotech stocks offers the potential for significant returns driven by breakthrough discoveries and advancements in healthcare, agriculture, and other industries.

Applied Therapeutics surges as FDA grants Priority Review to govorestat (AT-007) for Galactosemia treatment. If approved, it would be the first medication for Galactosemia. APLT also submits MAA to EMA, with a decision expected in Q4 2024. Private placement of $100 million.

The first new COPD treatment in a decade showed safety and effectiveness in a subset of patients with type 2 inflammation.

The application is supported by data from the randomized, double-blind, placebo-controlled phase 3 BOREAS and NOTUS trials.

Applied Therapeutics Inc (NASDAQ:APLT) shares are trading higher on Wednesday after the FDA accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for Classic Galactosemia. The NDA was granted Priority Review status, and the FDA assigned a Prescription Drug User Free Act (PDUFA) target action date of August 28, 2024. The FDA also noted that it plans to hold an advisory committee meeting to discuss the application. Govorestat was previously granted Pediatric Rare Disease de

The FDA accepted for Priority Review the sBLA for the SC formulation of efgartigimod alfa plus hyaluronidase-qvfc for the treatment of CIDP.

The application is supported by data from the phase 2 AGAVE-201 study.

Williamsport, Pa. — A new treatment for frostbite has just been approved by the federal Food and Drug Administration , but local doctors say prevention is still the best medicine.