The pharmaceutical supply chain and device development have become intricately linked. Harmonizing formulation development ...

Innovation drives speed in early phase drug development. ICON’s Accelerated Pharmaceutical Solutions integrate advanced ...

As the FDA unveils a parade of initiatives aimed at accelerating drug development for rare diseases, experts appeal for a ...

The R&D pipeline for depression therapies faced a demoralizing 2025 as five high-profile candidates, including KOR ...

Innovative outcome measures coupled with a focus on patient-centered clinical differentiation can help the biopharma industry ...

Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies ...

Writing in separate editorials in two leading medical journals, former chiefs of federal scientific agencies issued warnings ...

Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 ...

Praxis Precision Medicines has also announced a “successful” pre-NDA meeting with the FDA for its essential tremor drug ...

The ACIP decided 6–3 to postpone its vote on hepatitis B vaccination changes after the language of the questions was ...

Days after Johnson & Johnson’s posdinemab failed to slow clinical decline in patients with Alzheimer’s disease, Eisai Chief ...

Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s ...