The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...

A new compound, called VU319, has delivered promising results in a Phase 1 trial for treating Alzheimer's disease and other neudegenerative conditions. | Drug Discovery And Development ...

Subsequent New Drugs, Investigational New Drugs, Fixed Dose Combinations and Bioavailability & Bioequivalence studies," said Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), in a notice ...

PH-762 is a potential non-surgical treatment for skin cancers. The on-going Phase 1b trial (NCT# 06014086) received FDA clearance for an Investigational New Drug Application to evaluate PH-762 in the ...

(RTTNews) - Olema Pharmaceuticals (OLMA) announced the FDA has cleared Investigational New Drug application for OP-3136, a small molecule that potently and selectively inhibits KAT6, a validated ...

At the end of the screening period, Gubra and Amylyx anticipate identifying a lead development candidate to enter Investigational New Drug (IND)-enabling studies. Amylyx then has the option to lead ...

Sangamo Therapeutics shares lost more than half their value when Pfizer pulled out of a collaboration agreement.

today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OP-3136, a novel small molecule that potently and selectively ...

An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy. The term ...

today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OP-3136, a novel small molecule that potently and selectively inhibits ...

Lexaria Bioscience (NASDAQ: LEXX) , a global innovator in drug delivery platforms, remains on track for its upcoming Investigational New Drug (“IND”) submission. The application is for the company's ...

In spring 2024, CBER reported more than 70 investigational new drug applications (IND) that involved artificial intelligence (AI) or machine learning (ML) in some way. “We have seen remarkable p ...