Magdalena aiming to submit Investigational New Drug (IND) application in early 2025 to the FDA for a next-generation psychoactive prescription ...

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 ...

Nitroxoline has not been approved by the FDA, and its use is therefore considered investigational. FLA patients will receive ...

The trial is designed to assess the tolerability, efficacy, and safety of two different dosages of the therapy.

The company has already had a discussion with the FDA to pursue an investigational new drug (IND) application for NRC.

(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 ...

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 ...

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 ...

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

Detailed price information for Olema Pharmaceuticals Inc (OLMA-Q) from The Globe and Mail including charting and trades.