The application leverages existing clinical data for Uzedy along with prior FDA findings on the safety of Udezy in patients ...

Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...

Artificial intelligence improves process control and reduces the time required to produce key products such as the COVID-19 ...

The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has ...

The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a ...

Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the ...

GSK (GSK) announced that the China National Medical Products Administration, CNMPA, has accepted for review the new drug application for the ...

This new RXE is the second to receive acceptance by the FDA for a longevity drug developed by Loyal. The first, LOY-001, received RXE acceptance in November 2023. LOY-001 is a prescription injection ...

FDA clears LTZ's IND application to initiate trial of its myeloid engager immunotherapy to treat relapsed or refractory non-Hodgkin lymphoma.

Gireesh Babu, New Delhi Thursday, February 27, 2025, 08:00 Hrs [IST] ...

Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, stated: "We are delighted that the New Drug Application for Equecabtagene Autoleucel has been officially accepted by the Hong Kong ...