LIMINAL BIOSCIENCES: Announces FDA Extension of Review Period for Ryplazim®(plasminogen) BLA
PDUFA date extended by FDA from March 5, 2021 to June 5, 2021
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ALZHEIMER'S DRUG DISCOVERY FOUNDATION: Statement on Today's FDA Independent Panel Vote on Biogen's Aducanumab
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.
ORTHO CLINICAL DIAGNOSTICS: U.S. FDA Accepts Ortho's Emergency Use Notification for VITROS® SARS-CoV-2 Antigen Test--Capable of Accurate Mass-Scale Testing
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
ENGENE: Announces FDA Clearance of IND Application for EG-70, an intravesical dual-immune modulator for the treatment of non-muscle invasive bladder cancer
Phase 1/2 clinical study expected to begin in early 2021; EG-70 is enGene's first clinical-stage product candidate
FDA: Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection
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.
FDA: Takes Efforts to Protect Patients from Potentially Harmful Compounded Drugs Through Finalizing Insanitary Conditions Guidance
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.
JANSSEN: Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults
If approved, PP6M will be the first and only long-acting injectable schizophrenia treatment with a twice-yearly dosing regimen
TAIGEN: Announces FDA Approval of IND for Its Flu Antiviral TG-1000
TaiGen Biotechnology Company, Limited issued the following announcement on Nov. 1.TaiGen Biotechnology Company, Limited ("TaiGen") (Taiwan: 4157) announced today that U.S.
SALIX: Bausch Health's Rifaximin Receives FDA Orphan Designation For Sickle Cell Disease
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.
SPHERIX GLOBAL INSIGHTS: Eosinophilic Esophagitis, a Complex, Chronic Autoimmune Condition, Awaits FDA-Approved Therapies, Potentially Including a Biologic Option, According to Spherix Global Insights
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
ROCHE: Receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
Lung cancer causes more than 1.7 million deaths worldwide each year, with NSCLC accounting for about 85 percent of all cases
FDA In Brief: FDA Announces Investigations of Two Outbreaks of E. coli O157:H7 Illnesses
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.
THERAPEUTIC SOLUTIONS INTERNATIONAL: JadiCell™ Stem Cells Licensed by Therapeutic Solutions International for Brain Injury Significantly Increased Survival of COVID-19 Patients in Double Blind FDA Clinical Trial
Twenty-four Patient Clinical Trial Validates Superior Anti-inflammatory and Regenerative Properties of JadiCell™
REVISION THERAPEUTICS: Announces US FDA Grant of Rare Pediatric Disease and Orphan-Drug Designation for REV-0100 for the Treatment of Stargardt Disease
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.
AMGEN: Announces Participation Of Systemic Lupus Erythematosus (SLE) Adaptive Clinical Trial In The FDA Complex Innovative Trial Designs (CID) Pilot Program
Amgen and FDA Collaborate on Novel Clinical Trial Design to Advance Development of Potential Treatment for Patients With Uncontrolled SLE
We're Falling for Food Safety: Tips From FDA
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).
VANDA PHARMACEUTICALS: Receives FDA Approval to Proceed with Investigational New Drug VSJ-110 for Allergic Conjunctivitis
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.
MEDTRONIC: Venous Stent Receives U.S. FDA Approval to Treat Venous Outflow Obstruction
Abre™ Venous Self-Expanding Stent System Safe, Effective in Treating Challenging Deep Venous Lesions
JANSSEN: Submits Application to U.S. FDA for New Indication to Expand Use of XARELTO® (rivaroxaban) in Patients with Peripheral Artery Disease
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)
SANTEN: Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Cyclosporine Topical Ophthalmic Emulsion, 0.1% for the Treatment of Severe Vernal Keratoconjunctivitis in Patients Ages 4-18
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.