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.
Patient-Centric Engagement Platform Passes High-Level Compliance Greatly Benefiting Pharmaceutical Enterprises
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.
New Smartphone Connected Hybrid Closed Loop System Will Be Available to Individuals as Young as 2
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).
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.
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, 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, Inc. (NASDAQ: PTCT) announced that the company achieved a $20 million milestone payment from Roche under its License and Collaboration Agreement.
Clover's technology-first approach brings a new perspective to group of legacy payors
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.
Tepotinib granted Priority Review and is being evaluated under FDA Real-Time Oncology Review (RTOR) pilot program
RINVOQ demonstrated significant improvements to signs and symptoms of active ankylosing spondylitis[
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 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.
Approval broadens DARZALEX label to include fifth treatment option in the relapsed/refractory setting and represents the eighth approved indication for DARZALEX
AmideBio, LLC, a privately held biopharmaceutical company, announced that the US Food and Drug Administration (FDA) Offices of Pediatric Therapeutics and Orphan Products Development granted a rare pediatric disease designation to AmideBio's glucagon analog (AB-G023) for the treatment of congenital hyperinsulinism (CHI).
Kesimpta delivers powerful efficacy with a favorable safety profile and can be self-administered at home, addressing significant unmet needs for people living with relapsing forms of multiple sclerosis (RMS)
Approval Based on the CANDOR and EQUULEUS Studies in Patients With Relapsed/Refractory Multiple Myeloma
510(k) Clearance allows 23andMe to report interpretive drug information for medications prescribed for heart conditions and depression without the need for confirmatory testing