Bayer said the Food and Drug Administration extended the review period for its new drug application of elinzanetant, a treatment for moderate to severe vasomotor symptoms, also known as hot flashes, ...

Children in Mass. cannot have sunscreen applied by a teacher or camp staff member without prior permission from a doctor, ...

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.

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

The European Union's drug regulator has recommended approval of Moderna's updated formulation of COVID-19 shot Spikevax, the ...

Raleigh-based Focal Medical, an oncology device company that received early funding from the North Carolina Biotechnology Center, has been acquired by a Florida biopharmaceutical company. Financial ...

Toowoomba police have been accused of abusing their powers to stop and detain a Toowoomba man who was pulled up while walking ...

Institutional investors including Armistice Capital, RTW Investments, and Wellington Management have increased their exposure ...

Obamacare open enrollment is fewer than 100 days away, and huge uncertainties loom over how much millions of Americans will ...

The rapid emergence and re-emergence of viral pathogens—exemplified by outbreaks of influenza, Ebola, Zika, and, most recently, SARS-CoV-2—underscore the ...

A generic version of ibrutinib was granted tentative approval by the FDA for use in CLL and SLL with 17p deletion and ...

European Union approves GSK’s Blenrep combinations to treat relapsed/refractory multiple myeloma: London, UK Saturday, July 26, 2025, 11:00 Hrs [IST] GSK plc announced the appro ...