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As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
The federal government is tackling the issue of drug shortages from all sides, but the shortages continue to grow. Eighty percent of physicians report having patients affected by drug shortage and 100 percent of U.S. pharmacies report being affected by drug shortage, CDER’s Office of Pharmaceutical Quality (OPQ) Director Mike Kopcha told FDAnews. Read More
Novartis will pay up to $3.5 billion for Chinook Therapeutics for its pipeline of two high-value late-stage medicines for the treatment of rare, severe chronic kidney disease. Read More
Eisai’s antiamyloid antibody Leqembi (lecanemab) got a unanimous 6-0 thumbs-up from members of the FDA’s Central and Peripheral Nervous Systems Drugs Advisory Committee, who agreed that CLARITY-AD, the drug’s confirmatory study, showed that it conferred a significant clinical benefit to patients with mild cognitive impairment or early Alzheimer’s disease. Read More
Medical devices continue to take advantage of the technological advances we see in every part of our lives, from phones to virtual reality headsets, with several new devices seeing FDA clearances in the past few weeks. Read More
Over the past week, the FDA issued final guidances on nonclinical evaluation of the immunotoxic potential of pharmaceuticals, drug-drug interaction assessment for therapeutic proteins and cover letter attachments for controlled correspondence and draft guidances on interstitial cystitis/bladder pain syndrome and ICH E6(R3) guideline for good clinical practice. Read More
The FDA sketched out how it is implementing the fee structure of the Generic Drug User Fee Amendments of 2022 (GDUFA III) in a final guidance released Friday. Read More
The FDA should be as willing to withdraw an accelerated approval as to grant it, write a team of researchers, arguing for a balance between speed and certainty. Read More
The FDA’s Antimicrobial Drugs Advisory Committee, meeting Thursday, was overwhelmingly positive in its assessment of benefits and risks of AstraZeneca’s respiratory syncytial virus (RSV) preventive treatment, nirsevimab, for children. Read More
The FDA has finalized its guidance on drug-drug interaction (DDI) studies of investigational drugs with combined oral contraceptives (COC), outlining when these studies are and aren’t needed, how to design them and how to communicate findings. Read More
Eli Lilly has filed an appeal to the U.S. Court of Appeals for the Seventh Circuit following a May 9 decision that it violated the False Claims Act by underpaying rebates to Medicaid. Read More
The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the agency grant other requests Intarcia made last month. Read More