FDA: Requiring Labeling Changes for Benzodiazepines
Boxed Warning to Be Updated to Include Abuse, Addiction and Other Serious Risks
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FDA: Launches the Digital Health Center of Excellence
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).
FDA: Announces Key FSMA Rule to Advance Traceability of Foods, A Major Milestone in the New Era of Smarter Food Safety
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.
FDA: Issues first injunction under Produce Safety Rule to Illinois-based food manufacturer for repeated food safety violations
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.
SEQSTER: Streamlines Regulatory Submissions & Health Data Sharing with FDA 21 CFR Part 11 Compliance
Patient-Centric Engagement Platform Passes High-Level Compliance Greatly Benefiting Pharmaceutical Enterprises
U.S. FDA: National Food Safety Education Month: Do You Know the Steps for Food Safety?
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.
MEDTRONIC: Announces FDA Approval for MiniMed™ 770G Insulin Pump System with Smartphone Connectivity for People with Type 1 Diabetes
New Smartphone Connected Hybrid Closed Loop System Will Be Available to Individuals as Young as 2
SOFTWAVE® TISSUE REGENERATION TECHNOLOGIES: Receives FDA Clearance for the Treatment of Burn Wounds
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).
FDA: Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
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.
FDA: Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19
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
BEARPAC MEDICAL: Announces Commercial Launch of the New Passio Pump Drainage System After Receiving FDA 510(k) Clearance
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.
PTC THERAPEUTICS: Announces First Commercial Milestone Payment Following U.S. FDA Approval of Evrysdi™ (risdiplam)
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced that the company achieved a $20 million milestone payment from Roche under its License and Collaboration Agreement.
CLOVER HEALTH: Joins FDA's Early Payor Feedback Program to Encourage Innovation Among Medical Device Makers
Clover's technology-first approach brings a new perspective to group of legacy payors
RECORDATI RARE DISEASES INC.: U.S. FDA Approves CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A New Practical Treatment Option for the Ocular Manifestations of Cystinosis
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.
EMD SERONO: FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations
Tepotinib granted Priority Review and is being evaluated under FDA Real-Time Oncology Review (RTOR) pilot program
ABBVIE: Submits Regulatory Application to FDA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Ankylosing Spondylitis
RINVOQ demonstrated significant improvements to signs and symptoms of active ankylosing spondylitis[
REGENXBIO: Announces FDA Clearance of IND for Phase II Trial of RGX-314 for the Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery
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
HEALEON: Announces FDA 510(k) Clearance for Duet Office-Based Blood Separation and Concentration System
Healeon Duet enables customized concentrations of PRP at the point-of-care
LUNGEVITY: Launches Lung Cancer Patient Research Project in Collaboration with the FDA
The new multi-year study will seek to understand different aspects of the patient experience with lung cancer to improve treatment options and outcomes
KAZIA THERAPEUTICS LTD: US FDA Awards Orphan Drug Designation (ODD) To Paxalisib For Malignant Glioma, Including DIPG
Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of malignant glioma, which includes Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive childhood brain cancer.