The FDA is becoming deeply compromised and increasingly at risk of being permanently transformed in ways contrary to its ...

While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy ...

Also on Thursday, Zealand held its Capital Markets Day in London, outlining the strategy for its weight management franchise in the near-term, including launching five products by 2030.

Steven A. Grossman, JD, is President of HPS Group, LLC, a policy and regulatory consulting firm, and author of “FDA Matters: ...

Roche’s data on Wednesday come from the Phase III lidERA Breast Cancer study, which assessed the adjuvant use of giredestrant ...

Pfizer is in the midst of an aggressive, multi-year cost-cutting effort, which so far has left nearly 2,000 people jobless.

In this episode of Denatured presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, Mayo Clinic; Marilyn ...

The difference between a job and a career is what you walk away with when it ends. Here's how to evaluate if your role and ...

The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align ...

Backed by Italy-based Fondazione Telethon ETS, Waskyra, for Wiskott-Aldrich syndrome, is the first gene therapy from a ...

The FDA has informed Merck, Sanofi and AstraZeneca of the safety investigation into their RSV antibodies, though it remains ...

Pfizer deals again in obesity space as Wave and Structure drop splashy weight loss results; what CDER Director Richard Pazdur ...