The discovery and development of drugs in pharmacological research – including the risk assessment of active substances in ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR), a biopharmaceutical company with a market capitalization of $2.68 billion ...

An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...

Nicholson Nur, the Chief Technical Officer at Apellis Pharmaceuticals, Inc. (NASDAQ:APLS), a $3.86 billion market cap biotech company with strong revenue growth of 162% in the last twelve months, ...

The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.

The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...

The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...

The Federal Circuit has issued a precedential decision reversing a lower court’s decision that certain claims of Novartis’s ...

After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...

The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...

Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...

In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon ...