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

SGT-212 is the company's novel, AAV-based FA gene therapy candidate designed to deliver full-length frataxin via systemic intravenous (IV) infusion as well as direct intradentate nuclei (IDN) infusion ...

New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments.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

Additionally, the Phase 1 clinical trial evaluating QTX3034, an oral G12D-preferring multi-KRAS inhibitor, as a monotherapy and in combination with cetuximab, continues to enroll patients, and data is ...

Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with resistant hypertension. Additionally, untreated moderate-to-severe OSA increases the ...

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

Tenvie Therapeutics has unveiled with $200 million and the goal of transforming the neurological treatment landscape, nabbing ...

Shares of Solid Biosciences (NASDAQ:SLDB) jumped 11% post-market after the company said the FDA had cleared an ...

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

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 ...

Investigational once-weekly retatrutide yielded the greatest weight loss of all GLP-1 receptor agonists, up to 22.1% after 48 ...