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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

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.

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

NEURELIS: Announces FDA Approval Of Extended Expiration Dating For VALTOCO® (Diazepam Nasal Spray)

Neurelis, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company's lead product, VALTOCO® (diazepam nasal spray).

FDA: Approves First Treatment for COVID-19

U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.

AVIOQ: Announces FDA Approval of VioOne™ HIV Profile™ Supplemental Assay

Avioq, Inc. announces it has received approval from the U.S. Food and Drug Administration (FDA) for their VioOne™ HIV Profile™ Supplemental Assay.

LEO PHARMA: Announces U.S. FDA Approval for Enstilar® (calcipotriene and betamethasone dipropionate) Foam U.S. Prescribing Information Update to Include Data in Long-term Use in Plaque Psoriasis Treatment

U.S. Prescribing Information (USPI) updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly topical treatment with Enstilar® (calcipotriene and betamethasone dipropionate) Foam in adults with plaque psoriasis

FDA: Approves First Treatment for Ebola Virus

The U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.

CEFALY TECHNOLOGY: Now Over-the-Counter: FDA Clears CEFALY® DUAL Migraine Treatment for Use Without a Prescription

The first external Trigeminal nerve stimulator for the treatment of migraine headaches is now also the first available without a prescription

DIRECT BIOLOGICS: Granted Expanded Access by FDA for ExoFlo™ in the Treatment of COVID-19

Direct Biologics, LLC, announced today that the FDA has granted expanded access for ExoFlo in the treatment of patients with COVID-19 associated acute respiratory distress syndrome (ARDS).

CLYRA MEDICAL TECHNOLOGIES: Clyraguard, A Hospital-Grade, FDA-Registered Disinfectant For Face Masks And Coverings, Is Now Available To Consumers

Tested at Galveston National Laboratory, Clyraguard has shown complete inactivation of SARS-CoV-2 (COVID-19), providing an additional safeguard against airborne viruses

BIOSENSE WEBSTER: Receives FDA Approval for THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation

The CARTO® 3 System and THERMOCOOL SMARTTOUCH® SF Catheter allow for a patient-tailored ablation approach, resulting in high long-term effectiveness in persistent atrial fibrillation patients*

FDA: Approves Drug Combination for Treating Mesothelioma

First approval in 16 years for mesothelioma, a type of cancer caused by inhaling asbestos fibers

FDA: Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years

Approval is for hypereosinophilic syndrome, which occurs when there is a high number of a type of white blood cells

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