In the Guidance, the FDA posits that poor pharmaceutical label design can contribute to medication errors. To reduce such errors, the FDA seemingly takes a "pro-trade dress" stance by warning ...

A study recruited Black and Latina women and asked them to log all the beauty products they use in a week. Here's what the study found.

The draft guidance – which is open for comment until 7th April – proposes a risk-based assessment framework that drug developers ... such as user interface and labelling, data management ...

Increased 2025 guidance with expected net revenues of $768.0 million to $793.0 million, adjusted non-GAAP EBITDA of $195.0 ...

Molecular-guided decision-making improves disease control and remission in the treatment of IBD with anti-TNF therapy, however, application to other therapies is questioned.

Q1 2025 Earnings Call Transcript May 12, 2025 Xenon Pharmaceuticals Inc. beats earnings expectations. Reported EPS is $-0.83, ...

In March, the Company received FDA approval for an expanded label for ILUVIEN that includes YUTIQ's indication ... for the forward-looking full year 2025 adjusted EBITDA guidance because it does not ...

Biopharmaceutical company Bristol Myers Squibb (NYSE:BMY) reported Q1 CY2025 results , but sales fell by 5.6% year on year to ...

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...

A top agency official is meeting with industry and FDA staff as he works on guidance clarifying the FDA’s expectations for ...

Merck (MRK) stock in focus as the FDA approves its anticancer agent Welireg for two rare neuroendocrine tumors, expanding its ...

FDA to release new guidance soon, clarifying its regulatory framework related to vaccines, particularly COVID-19 shots. Read ...