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,…
After receiving an FDA notice of insanitary conditions at the Velocity Pharma supply plant, Cardinal Health and the Harvard Drug Group are voluntarily recalling all lots of their Velocity-produced ophthalmic…
In a guidance set to go into effect immediately, the FDA has made permanent the enforcement policy for use of clinical electronic thermometers it set during the COVID-19 public health…
A district court has ruled against an Alvogen subsidiary challenging the FDA’s rejection of its ANDA for a “skinny version” of Silax Pharmaceuticals’ blockbuster irritable bowel syndrome drug Xifaxan (rifaximin).…
Biotech products comprise nearly one-third of the $1.5 trillion global pharmaceutical market this year, according to a new Tufts Center for the Study of Drug Development (CSDD) study, with sales…