Company expects to initiate enrollment in the Phase II trial, ALTITUDE, in the second half of 2020 to evaluate the targeted, in-office suprachoroidal delivery of RGX-314
RINVOQ demonstrated significant improvements to signs and symptoms of active ankylosing spondylitis[
Tepotinib granted Priority Review and is being evaluated under FDA Real-Time Oncology Review (RTOR) pilot program
Recordati Rare Diseases Inc., announced the U.S. Food and Drug Administration (FDA) has approved CYSTADROPS® (cysteamine ophthalmic solution) 0.37%. CYSTADROPS is a new, viscous eye drop solution that depletes corneal cystine crystal deposits in people living with cystinosis.
Clover's technology-first approach brings a new perspective to group of legacy payors
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the company achieved a $20 million milestone payment from Roche under its License and Collaboration Agreement.
Bearpac Medical, LLC is pleased to announce that they have launched a new FDA 510(k) cleared device intended to treat patients with malignant and other recurrent pleural effusions.
As part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their
The U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes.
SoftWave® Tissue Regeneration Technologies, a disruptive bio-medical device company, was cleared by the FDA on Friday, Aug. 28, 2020, for the treatment of superficial, partial-thickness, second-degree burns in adults (FDA 510k letter number K200926).
New Smartphone Connected Hybrid Closed Loop System Will Be Available to Individuals as Young as 2
September is National Food Safety Education Month and it's the perfect time to learn the key steps for food safety: Clean, Separate, Cook and Chill.
Patient-Centric Engagement Platform Passes High-Level Compliance Greatly Benefiting Pharmaceutical Enterprises
The U.S. Food and Drug Administration announced that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.
The FDA has proposed a new rule that lays the foundation for the end-to-end food traceability across the food industry that we’ll be working toward over the next decade as part of the New Era of Smarter Food Safety initiative.
U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH).
Boxed Warning to Be Updated to Include Abuse, Addiction and Other Serious Risks
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the use of the ThinPrep® Pap Test™ PreservCyt® Solution vial as an approved sample type for its BD Onclarity™ HPV Assay.
U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.
Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin signaling.