At a meeting of the Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee, the majority of panel members voted against the approval of sotagliflozin (Zynquista™) ...
Following the clearance of an investigational new drug application from the FDA, a phase 1 trial will examine the novel ...
The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.
The FDA has extended its review of zenocutuzumab's in NRG1+ NSCLC and PDAC to February 2025, with efficacy and safety data ...
HACCP is a way of managing food safety hazards. Food safety management procedures should be based on HACCP principles. HACCP involves: looking closely at what you do in your business, what could go ...
The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday. The regulator approved Vyalev, also known as ...
Oct 17 - The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' (AVDL.O), opens new tab sleep disorder drug for children aged 7 years and older, broadening its use and heating ...
The Food and Drug Administration is issuing exemptions from the Drug Supply Chain Security Act’s current final implementation deadline for some drug manufacturers and distributors, according to ...
FDA to review if there's a shortage of tirzepatide Outsourcing Facilities Association lawsuit led to FDA reconsideration Shortages of Lilly and Novo Nordisk drugs drive demand for compounded ...
BERLIN--(BUSINESS WIRE)--Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for the investigational compound ...