Delcath Systems, Inc. announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that...
CSL Behring, a global biotherapeutics leader has received FDA) approval for its supplemental request (submitted Aug. 30, 2020) for co-packaging of a convenience administration kit along with its product Berinert, indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients.
Medtronic plc has announced new clinical data from the NAVABLATE study, which highlights the much anticipated safety and performance results on microwave ablation used bronchoscopically with the Emprint Ablation Catheter Kit with Thermosphere Technology in conjunction with the Medtronic electromagnetic navigation bronchoscopy system.
OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. announced that it has received the CE mark certification in the European Union for its OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19.
Qiagen announced the immediate launch of its Therascreen PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory...
Delcath Systems announced it submitted a new drug application (NDA) resubmission to the FDA for the HEPZATO Kit (melphalan hydrochloride for Injection/Hepatic Delivery System or Melphalan/HDS) seeking approval for the treatment of patients with unresectable hepatic-dominant metastatic ocular melanoma (mOM)
Vitagene has announced the availability of 50,000 FDA authorized at home Zero-Contact or Saliva-based COVID-19 test kits for use during the current public emergency to detect COVID-19.
Delcath Systems, Inc.announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for...