Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug ...

The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...

Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

The FDA has cleared the IND for Ensoma's EN-374, targeting X-linked chronic granulomatous disease (X-CGD), a rare genetic ...

Cytokinetics' PDUFA date for aficamten was extended to December 26th of 2025, due to the FDA's need to review a submitted ...

MPox is endemic in DRC, and has continued to cause large numbers of cases in the WHO African Region. In April, 2025, the WHO has restated that MPox continues to be a Public Health Emergency of ...

Evidence is mounting that clinicians can treat serious genetic disorders prenatally by injecting medicine into the amniotic ...

The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...

A new pill, tavapadon, has shown potential in easing Parkinson’s symptoms while limiting side effects. In patients taking at ...

The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.

FDA seeking 'aggressive' adoption of AI . The FDA announced an "aggressive timeline" to deploy artificial intelligence ...