As the FDA prepares for a busy Oncologic Drugs Advisory Committee meeting next week, an agency insider told BioSpace that ...

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

Despite recent challenges ranging from wildfires to economic uncertainty, Los Angeles remains a prime destination, not only ...

The White House has launched a new program focused on leveraging technology and private sector partnerships to find new ways to quickly produce key pharmaceutical ingredients and finished drugs at the ...

The FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.

Already, the agency has missed deadlines regarding several new drug applications. Drug patents are relatively short-lived, so big pharma companies must constantly launch new products to overcome ...

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

A low dose combination hormonal patch was found to be effective for pregnancy prevention based on results from a phase 3 study.

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

Biohaven secures $250 million from Oberland Capital, with total cash reaching $518 million to support troriluzole launch and operations.