Nearly half of rare oncology drug approvals include postmarketing requirements (PMR) for drug-drug interactions (DDI), a particular concern for cancer patients who are frequently being treated for co-morbidities and palliative…

In this edition of Quick Notes, we review recent FDA drug approvals of combination drug Truqap/Faslodex for breast cancer, DefenCath for hemodialysis patients, non-small cell lung cancer treatment Augtyro, a…

The FTC has filed an amicus brief amid the ongoing dispute between Viatris’ Mylan and Sanofi over the latter’s patents for Lantus insulin, assailing the use of improperly listed Orange…

The first systematic review using statistical methods to look at the risk of switching patients from reference biologics to a biosimilar, or the other way around, found no difference in…

Reorganization of two of the FDA’s larger offices in 2024 will bring about changes in how the agency handles inspections and drug assessments. Source: Drug Industry Daily

While the FDA has a longstanding requirement that risk information must be included in television and radio prescription drug ads, the final rule the FDA just issued focuses on ways…

Merck appears destined for another disappointment with its investigative cough suppressant gefapixant, after an FDA advisory committee almost universally panned the drug’s phase 3 data, citing an almost complete overlap…

The UK government, England’s National Health Service (NHS) and the Association of the British Pharmaceutical Industry (ABPI) have agreed to a drug pricing deal that will save the government £14…

As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…

The FDA has deemed B. Braun recall of its Space Volumetric Infusion Pump System due to a potentially faulty occlusion alarm that can stop the delivery of medications as class…