Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization
Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on ophthalmology, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cyclosporine topical ophthalmic emulsion, 0.1% for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18.
Application seeks approval of XARELTO® plus aspirin to reduce the risk of major thrombotic vascular events in patients after lower-extremity revascularization due to symptomatic peripheral artery disease (PAD)
Abre™ Venous Self-Expanding Stent System Safe, Effective in Treating Challenging Deep Venous Lesions
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to evaluate Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activator VSJ-110 (previously known as CFTRact-K267) for the treatment of allergic conjunctivitis.
As the weather gets cooler, you may find yourself wanting to spend more time baking or cooking in your kitchen or sipping a cup of cider. What better way to get cozy this fall than with a warm treat? To help you safely bake, cook, and enjoy your cider this season, the U.S. Food and Drug Administration (FDA) offers food safety tips that can help you avoid foodborne illness (also known as food poisoning).
Amgen and FDA Collaborate on Novel Clinical Trial Design to Advance Development of Potential Treatment for Patients With Uncontrolled SLE
reVision Therapeutics, Inc., a privately-held, early stage biopharmaceutical company focused on the development and commercialization of innovative therapies for ocular and rare diseases, announced that the US Food and Drug Administration has granted the Company's request to designate REV-0100 as an Orphan-Drug and a Rare Pediatric Disease Drug for the treatment of Stargardt disease.
Twenty-four Patient Clinical Trial Validates Superior Anti-inflammatory and Regenerative Properties of JadiCell™
The FDA, along with the CDC and our state and local partners, are working to investigate two outbreaks of Shiga toxin-producing E. coli O157:H7 (STEC) illnesses.
Lung cancer causes more than 1.7 million deaths worldwide each year, with NSCLC accounting for about 85 percent of all cases
With both steroid-based and advanced therapies poised for FDA approval in the near term, gastroenterologists' general satisfaction with current eosinophilic esophagitis treatment options is not optimal
Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and its gastroenterology business, Salix Pharmaceuticals ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to rifaximin for the treatment of sickle cell disease.
TaiGen Biotechnology Company, Limited issued the following announcement on Nov. 1.TaiGen Biotechnology Company, Limited ("TaiGen") (Taiwan: 4157) announced today that U.S.
If approved, PP6M will be the first and only long-acting injectable schizophrenia treatment with a twice-yearly dosing regimen
Protecting patients from exposure to poor quality compounded drugs is a fundamental part of the U.S. Food and Drug Administration’s drug compounding program, and we are committed to protecting patients.
The U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.
Phase 1/2 clinical study expected to begin in early 2021; EG-70 is enGene's first clinical-stage product candidate
Offered with 100 percent sensitivity[i] with samples with a PCR Cycle Threshold (CT) of less than 34, Ortho's test may be better able to identify individuals with COVID-19 who are infectious compared to PCR
An independent FDA advisory committee today signaled in several votes that it does not believe the clinical study data for Biogen's aducanumab supports the drug's approval for patients with early stage Alzheimer's disease.