The FDA published a pair of final guidances Friday meant to assist drugmakers by providing technical specifications for submitting general clinical outcome assessment (COA) data and patient-reported outcome (PRO) data…
The FDA wants its Radiological Devices Advisory Panel to weigh in on whether irradiators used to prevent metastasis in salvaged blood during cancer surgeries are safe enough to be classified…
The European Commission’s (EC) proposals to reduce a component of intellectual property protection for breakthrough medicines will hasten a trend which has seen Europe’s position as a global innovator deteriorate…
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 smacked Natco Pharma for contamination problems and quality control lapses following an inspection of its Rangareddy, Telangana, India facility from Oct. 9 to 18. Source: Drug Industry Daily
With the looming expiration of temporary government funding on Nov. 17, lawmakers face significant challenges to reconciling the House and Senate versions of fiscal 2024 appropriations bills — including one…
This month, FDAnews tackles Amgen’s promising phase 2 study on tarlatamab for SCLC, AbbVie’s Skyrizi and Lilly’s Mirikizumab take on Stelara and 10 year study results for Roche’s Ocrevus for…
Many pre-approval inspections that were in limbo because of the backlog during the pandemic are now going ahead and the uptick could result in more product approvals, according to regulatory…
Over the past week, the FDA issued final guidances on enforcement for certain supplements for PMA or HDE submissions and clinical electronic thermometers enforcement policy. The agency is also proposing to…
In this edition of Quick Notes, we cover drug approvals for Roche’s Vabysmo for macular edema, Servier’s Tibsovo for treatment of IDH1, Coherus’ and Shanghai Junshi Biosciences’ Loqtorzi for nasopharyngeal cancer,…