On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...more
On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs....more
On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The...more
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more
4/3/2023
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Marketing Authorization Application ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health Emergency
Summary: An ANDA was held not to infringe asserted claims because the ANDA specifies pH ranges that fall outside of those recited in the asserted claims....more
(Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order the granting of U.S. Application No. 14/509,809 (‘809), titled “Anti-FOLR...more