The U.S. Food and Drug Administration is providing an update on its investigation into reports of dilated cardiomyopathy (DCM) in dogs eating certain types of pet food.
The FDA is committed to making sure that health care professionals and patients have up-to-date, accurate and actionable information about prescription medications so that informed treatment decisions can be made. We recognize that the choice of which medication to use, if any, for a particular patient is often a complex decision.
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Patients who receive fecal microbiota for transplant (FMT) are at risk of life-threatening infections, the Food and Drug Administration said.
The U.S. Food and Drug Administration approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord.
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U.S. District Judge Ursula Ungaro of the Southern District of Florida issued an order that stops US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D., from manufacturing or distributing any and all stromal vascular fraction (SVF) products, which are adipose (fat) tissue derived stem cell products, until they come into compliance with the law.
U.S. Marshals seized over 300,000 containers of Life Rising Corporation’s dietary supplements in a raid requested by the Food and Drug Administration.
The FDA has been working on methods to determine how much per- and polyfluoroalkyl substances (PFAS) are in foods. Initial testing was done on foods common in the American diet.
The Food and Drug Administration recently approved the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000.
Combination regimen reduced the risk of disease progression or death by 44 percent in newly diagnosed patients who are transplant ineligible
Seven outbreaks of foodborne illnesses have been reported so far this year, according to the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
The U.S. Food and Drug Administration expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.
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Vertex's third medicine approved to treat the underlying cause of CF in eligible patients in this age range
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DEXTENZA Now Approved for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery
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Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental biologics application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity. BOTOX® was granted a six-month Priority Review by the FDA, which is typically granted to therapies that if approved, could offer significant improvements in safety and effectiveness when compared to current standard of care.
Jane Orient, executive director of the Association of American Physicians and Surgeons and president of Doctors for Disaster Preparedness, believes it’s the latest example of chemophobia.
The FDA is working toward better regulation of cannabis-based products, consulting services firm Kline said after a public hearing with the U.S. regulatory body.
Food producers carried out 46 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
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Camurus (NASDAQ STO: CAMX), a commercial stage biopharmaceutical company specializing in long-acting medicines for severe and chronic disorders, announced today the acceptance by the US Food and Drug Administration (FDA) of an Investigational New Drug (IND) application to initiate a Phase 3 study with CAM2029 once-monthly octreotide subcutaneous depot for treatment of acromegaly.
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