Less than a year after garnering the first anti-CLDN18.2 approval in the U.S., Astellas Pharma is not resting on its laurels.

Instead, Stealth submitted a new drug application (NDA) seeking approval of elamipretide and the FDA issued its ...

The FDA and Stealth look set to relitigate the debate, with the biotech planning to file for approval once again. Stealth has ...

Intellia Therapeutics’ stock may have taken a hit in the wake of details of a grade 4 adverse event in a phase 3 trial, but ...

Keros Therapeutics is ending development of a phase 2 candidate designed to treat high blood pressure in the lungs, a move ...

After Merck paid a hefty sum to co-develop and co-commercialize HER3-DXd, the drug has suffered notable setbacks in ...

But on Wednesday, May 28 Moderna revealed the HHS has terminated the award for late-stage development and right to purchase ...

A Dutch neuromodulation developer has raised $60 million to complete the development of its minimally invasive implant for ...

Months after causing safety concerns that led the FDA to hit a related trial with a clinical hold, a phase 2 trial of ...

Almost all the patients with depression who received Gilgamesh Pharmaceuticals’ psychedelic drug candidate went into ...

GSK’s decision to swoop in and save Spero Therapeutics’ antibiotic three years ago appears to have paid off based on a fresh ...

Eli Lilly is expanding its efforts to advance next-generation pain medications. | Eli Lilly is expanding its efforts to ...