Warnings mark a first for FDA about OTC topicals rendered unapproved due to labeling for STI treatment and latest action to ...

A bipartisan Senate bill that would end the Trump Administration’s 340B rebate model pilot and create a national claims ...

Kevin Lobo announced plans to step down as Stryker's CEO after 14 years in the role and 15 with the company, during which the ...

HHS' attorney said professional organizations cannot challenge the ACIP member appointments because no final agency action ...

Novo will not submit its Ozempic/Wegovy/Rybelsus franchise and AstraZeneca refused to enter its Calquence into the 340B ...

The National Institute of Allergy and Infectious Diseases also is weighing whether to participate in trials involving ...

Consumer health sales are growing across the Nordics and access to non-prescription products is widening, but Conaxess ...

CNS drug development has long presented significant challenges. Diseases can be severe and chronic, diagnoses may take years, ...

MHRA will update its definition of “medical device” when it sets out implementation plans for a new AI regulatory framework ...

The global coalition of medicines regulatory authorities, ICMRA, is pressing regulators to align acceptance of non-animal ...

The long-acting injectable was superior to daily oral therapy at viral suppression in treatment-experienced patients who had ...

Members of Congress are calling on Revlon to address FDA-identified talc-testing deficiencies at its North Carolina facility ...