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The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 1 with one abstention to recommend that the FDA restrict approval for the combination of AstraZeneca’s blockbuster cancer drug Lynparza (olaparib) and Zytiga (abiraterone) to just metastatic castration-resistant prostate cancer (mCRPC) patients whose tumors have a breast cancer gene (BRCA) mutation. Read More
The FDA requires devicemakers to verify that a product meets each of its design specifications, which is generally accomplished through postproduction inspection or testing. Read More
Takeda has another shot on goal for a self-administered subcutaneous form of its blockbuster Entyvio (vedolizumab) as maintenance treatment for patients with ulcerative colitis who have completed induction therapy with the antibody’s intravenous form. Read More
The FDA has warned users of a vulnerability in Illumina’s genetic sequencing devices that could allow an authorized user to make changes to data from the devices. Read More
Over the past week, the FDA issued an authorization of a medical device, a request for comments for a public workshop and proposed data and information collections. Read More
The European Medicines Agency’s (EMA) human medicines committee has signed off on GSK’s Arexvy (recombinant, adjuvanted), the first respiratory syncytial virus (RSV) vaccine for adults age 60 years and older as well as six other new drugs at its latest monthly meeting. Read More
Akorn Pharmaceuticals is recalling dozens of unexpired human and animal drug products in connection with a Chapter 7 bankruptcy filing, ending a five-year struggle to stay afloat through court battles and regulatory enforcement actions. Read More
Starting in September, the European Medicines Agency (EMA) will begin gradually resuming its efforts to openly share clinical trial data for medical products, the agency reported. Read More
Egypt’s Pharmaplast received an FDA warning letter on April 13 for failing to address drug component testing and equipment maintenance issues. Read More
Elkhart-Ind.-based Voyant Beauty, a division of Accra-Pac, received an FDA warning letter on April 20 for not appropriately addressing benzene contamination of its over-the-counter topical aerosol products, found during an Aug. 23-Sept. 2, 2022 inspection. Read More
Significantly modifying its Velopex Aquacut fluid abrasion unit in multiple ways without submitting a new 510(k) clearance application has resulted in the UK’s Medivance Instruments receiving a Feb. 13 warning letter from the FDA. Read More
To help device manufacturers avoid the most common reasons for delays in technical documentation reviews — incomplete submissions and a lack of cohesive structure — the nonprofit European Association of Medical Devices Notified Bodies (dubbed Team NB) has published a compilation of guidance from many notified bodies in a set of best practices. Read More