The FDA is citing new evidence that problematic use and overdose risk go up when taking opioid analgesics for long-term pain ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody; binds to unique CD38 epitope Phase 1 study in adults with active and chronic active renal allograft AMR planned to initiate AMR is ...

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.

The majority of Teva's business lies in generic and off-patent branded drugs which faces price and volume pressures that will be exacerbated as regulatory actions and other players in the drug supply ...

Detailed price information for Aldeyra Therapeu (ALDX-Q) from The Globe and Mail including charting and trades.

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its proprietary CDH17-targeting antibody-drug conjugate (ADC), 7MW4911, has received ...

The advent of artificial intelligence (AI) at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices.

Detailed price information for Replimune Group Inc (REPL-Q) from The Globe and Mail including charting and trades.

Almost 400 people died as a result of drink and drug-driving last year, and the government is considering introducing tougher regulations as a result ...