Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.

New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments. Read more here.

The company announced that the first subjects have been dosed in a Phase-1 clinical trial of SUVN-I6107 in the USA.

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

Recursion announced that the UK Medicines and Healthcare Products Regulatory Agency has cleared a clinical trial application for a Phase 1 ...

GSK announced on Tuesday that its investigational antibody-drug conjugate GSK'227 has been granted breakthrough therapy ...

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 ...

In studies by Massachusetts General Hospital, the AbbVie-Calico collaborative drug and Denali Therapeutics' own drug failed to meet endpoints for treating amyotrophic lateral sclerosis, more widely ...

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 ...

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

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 ...

BioAge Labs (NASDAQ: BIOA) , a biopharmaceutical company focused on metabolic diseases, is facing a class-action lawsuit from shareholders who allege the company misled investors about the safety and ...