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The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SME) in the pharmaceutical sector, including updates to reflect new EU regulations, guidance for working with technology and data and collaborating outside the EU. Read More
Sanofi and Inhibrx, a clinical-stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates, today announced a $2 billion agreement for Sanofi to acquire Inhibrx. Read More
The FDA’s newest draft guidance addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate, or a combination of those materials. Read More
This edition of Quick Notes looks at the FDA approving devices and systems that detect and/or offer treatment for potential skin cancer, Alzheimer’s, lung fibrosis and diabetic neuropathy. Read More
A boxed warning has been added to the labeling for Prolia (denosumab) based on FDA review of information on the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
CDRH set a new record last year, says its latest annual report, granting marketing authorization to 124 novel devices, excluding emergency use authorizations (EUAs), the highest in the more than 40-year history of the center. Read More
The FDA has warned Novartis that its direct to consumer TV ad for its breast cancer drug Kisqali (ribociclib) makes false or misleading representations about the drug’s efficacy, sending the company an untitled letter. Read More
CMS and the FDA have issued a rare joint statement advocating for the oversight of laboratory developed tests (LDT) by both agencies, rather than keeping it solely within CMS. Read More
Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Read More
High drug prices and barriers to generic drugs are the targets of Sens. Amy Klobuchar (D-Minn.) and Bernie Sanders (I-Vt.) who are seeking answers from pharmaceutical manufacturers. Read More
Federal watchdog the General Accounting Office (GAO) will be investigating the FDA and its oversight of medical device recalls, highlighted by health crises related to Philips Respironics’ ventilators and CPAP devices. Read More