FDA issues Disc Medicine a complete response letter for its experimental therapy bitopertin, indicated for treating erythropoietic protoporphyria.
FDA cites Zydus Lifesciences sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic processing deficienci...
Singer further suggests that Congress could explore forms of international drug reciprocity, allowing Americans to purchase certain drugs over the cou...
A law firm examines FDAs renewed scrutiny of direct-to-consumer television advertising after issuing seven untitled letters so far in 2026.
Medline recalls (Class 1 device correction) certain Medline homecare beds as a Class I recall, warning that continued use without updated instructions...
FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...
Public Citizen petitions HHS to use existing law to eliminate patent barriers that prevent the entry of generic forms of Novo Nordisks and Lillys GLP-...
Hyman, Phelps & McNamara attorney Peter Dickos reviews a Florida federal court decision that said FDA Warning Letters sent to Hybrid Pharma became rev...
