Stemell sold stem cell products without required FDA approval
Inotrem S.A., a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nangibotide development program for the treatment of septic shock.
Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases.
Ra Pharmaceuticals, Inc. (Nasdaq:RARX) today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to zilucoplan for the treatment of myasthenia gravis.
Following the death of an Illinois citizen who suffered from respiratory illness after vaping, Sen. Dick Durbin (D-IL) sent a letter to the Food and Drug Administration and the Center for Tobacco Products demanding that they remove e-cigarettes and related vaping products off of the market.
The Food and Drug Administration gave the go-ahead last week to accept Seelos Therapeutics’ application for a new drug to combat Sanfilippo syndrome, a rare genetic defect.
NDA Submitted under the FDA’s Accelerated Approval Program
Company granted 180 days of exclusivity under FDA Competitive Generic Therapy approval pathway
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).
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 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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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.
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).
Designation Underscores Urgent Need for New Antifungals Targeting Multidrug-Resistant Pathogens
Interstitial lung disease (ILD) is the leading cause of death among people with systemic sclerosis (SSc) or scleroderma
The Coconut Coalition of the Americas (CCA), announced the launch of an initiative to make it clear that coconuts are not tree nut allergens.
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.
Once daily Aczone® 7.5% Gel is proven to treat acne vulgaris in 12 week clinical studies
Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of Abicipar quarterly dosing regimen
Omeros Remains On Track to Initiate the Submission Next Quarter