Wednesday, November 13, 2024

Wednesday, November 13, 2024

Latest News

PERRIGO: Announces FDA Approval for the Store Brand Equivalent of Voltaren® Arthritis Pain

Perrigo Company plc (NYSE: PRGO; TASE) announced that it was the first to receive approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA)

LUMINEX: Receives FDA Emergency Use Authorization for ARIES® SARS-CoV-2 Assay to Detect Virus Responsible for COVID-19 Disease

Luminex is now able to provide SARS-CoV-2 diagnostic tests for both high-complexity, high-throughput reference labs and moderate complexity, sample-to-answer testing facilities

NITILOOP: Nitiloop's NovaCross Earns FDA Clearance for Treating Chronic Total Occlusion (CTO) Prior to PTCA or Stent Intervention

Designed solely for antegrade approach, NovaCross™ is positioned to tap into the $500M CTO market, a market with only few players

SECTRA, INC.: Sectra and Hospital for Special Surgery Collaborate to Integrate FDA Approved Digital Pathology Imaging Solution

International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has gone live with an initial phase of its digital pathology solution at New York's Hospital for Special Surgery (HSS), the world's leading academic medical center focused on musculoskeletal health.

POLARYX THERAPEUTICS: Receives IND Approval From the FDA to Study PLX-200 Treatment for Patients With Juvenile Neuronal Ceroid Lipofuscinosis

Polaryx Therapeutics, a biotech company developing patient-friendly, small molecule therapeutics for lysosomal storage disorders, announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) to study PLX-200 treatment on Juvenile Neuronal Ceroid Lipofuscinosis (JNCL or CLN3) patients.

FDA: Approves First Generic of a Commonly Used Albuterol Inhaler to Treat and Prevent Bronchospasm

The U.S. Food and Drug Administration approved the first generic of Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation, for the treatment or prevention of bronchospasm in patients four years of age and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group.

EICOSIS: EC5026 Granted Fast Track Designation by FDA for Neuropathic Pain

EC5026 is the first soluble epoxide hydrolase inhibitor developed to treat neuropathic pain

FDA: Coronavirus (COVID-19) Update: FDA Authorizes Blood Purification Device to Treat COVID-19

The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

CYTOSORBENTS: U.S. FDA Grants CytoSorb® Emergency Use Authorization for Use in Patients with COVID-19 Infection

CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients with COVID-19 infection.

B. BRAUN: Receives FDA Emergency Use Authorization for Use of Infusion Pumps with Nebulizers to Treat COVID-19 Patients

Action Allows Perfusor® Space, Infusomat® Space, and Outlook® ES Pumps to be Used for Tracheal Delivery of Continuous Nebulized Medications into a Nebulizer

AVM BIOTECHNOLOGY: FDA Approval for Clinical Trials for Promising New Cancer Treatment

Seattle's AVM Biotechnology announces clinical trial approval for AVM0703, an exciting new drug to treat terminal no-option Non-Hodgkins Lymphoma, Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia.

ORTHO CLINICAL DIAGNOSTICS: Ortho's Total Antibody Test for COVID-19 Receives Emergency Use Authorization from FDA

The U.S. Food and Drug Administration (FDA) announced it granted Emergency Use Authorization to Ortho Clinical Diagnostics' total antibody assay for COVID-19—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.

VAULT HEALTH: Launches First-of-its-Kind Saliva-based FDA EUA Approved Test for COVID-19

Vault will make thousands of saliva tests available nationwide with RUCDR Infinite Biologics

FDA: Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer

U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC).

FDA: Coronavirus (COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

As part of the all-of-America approach to fighting the COVID-19 pandemic, the U.S. Food and Drug Administration has been working with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to treat this novel virus.

TISSUETECH: Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from U.S. Food and Drug Administration

RMAT designation reinforces clinical significance of investigational biologic product TTAX02 used during in-utero fetal surgical repair of spina bifida

LIPOCINE: U.S. FDA Denies Clarus's Oral Testosterone Ester Citizen Petition

Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the United States Food and Drug Administration ("FDA") denied the Citizen Petition filed by Clarus Therapeutics Inc. ("Clarus") on October 2, 2019.

FDA Health News