The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...

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

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New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments.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

The FDA granted orphan drug designation to amezalpat in hepatocellular carcinoma based on phase 1b/2 data showing efficacy ...

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 ...

Summit Therapeutics (SMMT) stock received a new buy rating from Truist based on its deal-forming prospects in oncology. Read ...

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 ...