During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023, to keep you updated on laws and…

This edition of Quick Notes features approvals for Adaptimmune’s Tecelra, Purdue Pharma’s Zurnai, Servier Pharmaceuticals’ Voranigo and Aurobindo’s Estradiol. Source: Drug Industry Daily

Velocity Pharma’s lack of oversight of the quality of the eye drops its contract manufacturer — Kilitch Healthcare India Limited who received its own Warning Letter for the eye drops…

Cresilon has received FDA clearance for its plant-based hemostatic gel technology Traumagel to be used to stop and control life-threatening bleeding in a matter of seconds when applied to a…

This week, the FDA issued rules on new device classifications for SARS-CoV-2 detection devices, devices that detect select microbial agents and some intravenous catheter separation devices. The agency also announced…

Omega Tech Labs received an FDA Warning Letter for inadequate procedures to prevent microorganisms in its combination product and failure to meet water quality standards in manufacturing following a Jan.…

Breas Medical has initiated a nationwide correction for 8,186 of its Vivo 45 LS ventilator devices after internal testing identified the potential for short term elevated levels of formaldehyde exposure…

Amgen filed a lawsuit against Samsung Bioepis for infringing 34 patents that cover denosumab, the active ingredient in Prolia and Xgeva, drugs used to treat bone loss. Source: Drug Industry…

Novartis’ 2022 complaint against several generic drugmakers for allegedly infringing on a patent for its blockbuster heart failure drug Entresto (sacubitril/valsartan) was denied on Tuesday, but the judge gave the…

From a warning that the new pricing scheme doesn’t mean patients are protected from increased costs to another that the Inflation Reduction Act (IRA) pricing scheme will limit patients’ access…