TRICIDA: Announces Submission of New Drug Application for Veverimer for the Treatment of Metabolic Acidosis in Patients with Chronic Kidney Disease
NDA Submitted under the FDA’s Accelerated Approval Program
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AMNEAL PHARMACEUTICALS: Announces Approval of Generic Version of Amicar®
Company granted 180 days of exclusivity under FDA Competitive Generic Therapy approval pathway
LINEAGE CELL THERAPEUTICS: Announces Issuance of U.S. Patent for Method of Treating Spinal Cord Injury With Stem Cell-Derived Oligodendrocyte Progenitor Cells
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,286,009, entitled “Pluripotent stem cell-derived oligodendrocyte progenitor cells for the treatment of spinal cord injury” covering methods for utilizing pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) for the treatment of spinal cord injury (SCI).
FDA Update: August medical device recalls
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
VIELA BIO: Announces Publication in The Lancet of Pivotal Study Results of Inebilizumab in Patients with Neuromyelitis Optica Spectrum Disorder
Viela Bio today announced that peer-reviewed journal, The Lancet, has published results from its pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain.
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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for patients with rare type of lung disease
The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition.
GBT: Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Voxelotor for the Treatment of Sickle Cell Disease
Global Blood Therapeutics, Inc. (GBT) (NASDAQ: GBT) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) seeking accelerated approval for voxelotor, an oral, once-daily therapy in development for the treatment of sickle cell disease (SCD).
AMPLYX PHARMACEUTICALS: FDA Grants Fast Track Status to Amplyx Pharmaceuticals for IV and Oral Formulations of Fosmanogepix (APX001) for Seven Different Indications
Designation Underscores Urgent Need for New Antifungals Targeting Multidrug-Resistant Pathogens
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.: FDA approves Ofev® as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD
Interstitial lung disease (ILD) is the leading cause of death among people with systemic sclerosis (SSc) or scleroderma
COCONUT COALITION OF THE AMERICAS: The Coconut Coalition of the Americas Launches Initiative to Remove Coconut From the FDA Major Food Allergen List
The Coconut Coalition of the Americas (CCA), announced the launch of an initiative to make it clear that coconuts are not tree nut allergens.
JENKINS EYE CARE: Offers First and Only FDA-approved Trifocal Lens: AcrySof IQ PanOptix Trifocal IOL
Ophthalmological surgeons Tyrie Jenkins, M.D. and Jeffrey Peterson, M.D., Ph.D., of Jenkins Eye Care, now offer cataract patients a trifocal lens that provides a combination of near, intermediate and distance vision.
ALMIRALL: Aczone® (dapsone) Gel, 7.5% Now Approved for the Topical Treatment of Acne Vulgaris in Patients 9 Years of Age and Older
Once daily Aczone® 7.5% Gel is proven to treat acne vulgaris in 12 week clinical studies
ALLERGAN PLC: Allergan and Molecular Partners Announce Acceptance of U.S. FDA Biologics License Application and Validation of EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration
Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of Abicipar quarterly dosing regimen
OMEROS CORPORATION: FDA Confirms Omeros’ Schedule for Rolling Review of the Company’s BLA for Narsoplimab in the Treatment of HSCT-TMA
Omeros Remains On Track to Initiate the Submission Next Quarter
PUMA BIOTECHNOLOGY: Announces U.S. FDA Acceptance of Supplemental New Drug Application for Neratinib to Treat HER2-Positive Metastatic Breast Cancer
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy (third-line disease).
FDA Update: July facility inspection results
The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.
FDA issues warning about three Hepatitis C medications
The FDA is warning that certain Hepatitis C treatments can cause further damage to the livers of people with advanced cases of liver disease.
Sandoz Inc. recalls Losartan Potassium, Ezetimibe
Sandoz Inc. is recalling two medications that treat cholesterol and high blood pressure because the bottles they were packaged in failed to meet child-resistant closure requirements.
FDA confirms guidance on placebos, blinding for cancer trials
The Food and Drug Administration (FDA) made a recommendation to drugmakers last week stating that they only use placebos in cancer clinical trials in select circumstances.
XERIS PHARMACEUTICALS: Receives U.S. FDA Approval for GVOKE™ (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia
First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies