FRIDAY, April 19, 2019 — The first generic naloxone nasal spray to treat opioid overdose has received approval from the U.S. Food and Drug Administration. Teva Pharmaceuticals’ lifesaving product is also the first generic naloxone nasal spray approved for use by people without medical training. There was already a brand-name spray (Narcan) for emergency use […]Continue Reading ...
April 11, 2019 — The U.S. Food and Drug Administration today issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the drug. The changes are the result […]Continue Reading ...
Today, the U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. In a new safety communication, the FDA warned that such tools -; such as apps on a […]Continue Reading ...
The U.S. Food and Drug Administration and the U.S. Customs and Border Protection (CBP) leaders signed an agreement today to maximize inspection and detection capabilities in order to prevent illegal and harmful products entering the U.S. through the nation’s International Mail Facilities (IMFs) and Ports of Entry that pose a threat to public health. Through […]Continue Reading ...
LOUISVILLE, Ken., April 1, 2019 /PRNewswire/ — US WorldMeds has announced that Sloan Pharma, S.a.r.l., a subsidiary of US WorldMeds Holdings, LLC, has received approval from the U.S. Food and Drug Administration (FDA) for the reintroduction of Zelnorm™ (tegaserod), a twice-daily oral treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women under 65. Zelnorm […]Continue Reading ...
Treatment for Gastroparesis Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti NDA SOLANA BEACH, Calif., April 02, 2019 (GLOBE NEWSWIRE) — Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has received a Complete Response Letter (CRL) […]Continue Reading ...
Home News Professional FDA Approves Mayzent for Relapsing Multiple Sclerosis WEDNESDAY, March 27, 2019 — Mayzent (siponimod) pills have been approved by the U.S. Food and Drug Administration for adults with relapsing multiple sclerosis. Mayzent’s effectiveness was shown in clinical studies of 1,651 patients. Progression of disability was significantly lower among those who took Mayzent […]Continue Reading ...
Brussels, Belgium – 29 March 2019 – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for Cimzia (certolizumab pegol) to include a new indication for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. The approval makes […]Continue Reading ...
The U.S. Food and Drug Administration today issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the drug. The changes are the result of the FDA’s review […]Continue Reading ...
FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency RAMSEY, N.J. and BOCA RATON, Fla., April 01, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops plasma-derived biologics for the treatment of immune deficiencies and […]Continue Reading ...
Home News FDA Alerts E-cigarette: Safety Communication – Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults April 3, 2019 [Posted 04/03/2019] AUDIENCE: Consumers, Emergency Medicine, Health Professionals ISSUE: The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult […]Continue Reading ...
In this Jan. 31, 2012 file photo, a farm worker carries heads of romaine lettuce in a field near Holtville, Calif. In a Nov. 15, 2018 email, James Gorny, a senior science adviser for produce safety at the FDA, wrote that growers “cannot cling to their generic E. coli monitoring standard,” which he called “unacceptable.” […]Continue Reading ...
The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C. The FDA previously warned the public about the agency’s serious concerns with the quality of drug products […]Continue Reading ...
Mar 27 2019 AMSBIO offers an unmatched portfolio of over 2000 tissue microarrays (TMAs), one of the best sample formats for rapid detection of cellular localization of RNA and protein expression. Recently, the company introduced US Food & Drug Administration (FDA) standard TMAs for human, mouse and rat to its portfolio. Designed in close conformance […]Continue Reading ...
WEDNESDAY, March 27, 2019 — A new pill for relapsing forms of multiple sclerosis (MS) has won approval from the U.S. Food and Drug Administration. Generally, relapsing MS involves periods of worsening symptoms followed by recovery periods. Over time, some disability follows independent of relapses, and this is called secondary progressive multiple sclerosis, or SPMS. […]Continue Reading ...
- Making Laboratories More Efficient with the Most Modern LIMS on the Market
- Treating cancer patients with personalized, combination therapies improves outcomes
- Researchers engineer new molecules to help stop lung cancer
- Acupuncture can be a wonderful tool for preventing number of diseases
- Daily life disability before hip replacement may predict poor post-operative outcomes
- Study finds involuntary staying in housing estates to be a potential health risk
- Older kidney disease patients starting dialysis die at higher rates than previously thought
- Time-restricted eating shows promise for controlling blood glucose levels
- Research provides important insight on the brain-body connection
- In 10 Years, Half Of Middle-Income Elders Won’t Be Able To Afford Housing, Medical Care
- Researchers study how E. coli clones have become major cause of drug-resistant infections
- Bacterial and fungal toxins found in popular electronic cigarettes
- Factors affecting absorption of ‘sunshine vitamin’ during spring/summer months
- Texting helps improve medication adherence, health outcomes for patients with schizophrenia
- Cochrane Review looks at different ways to use nicotine replacement therapies
- New review on relationship between COPD and Type 2 diabetes
- Brain areas linked to memory and emotion aid odor navigation in humans
- Brain stimulation reverses age-related memory loss
- Amid Opioid Prescriber Crackdown, Health Officials Reach Out To Pain Patients
- $4 million NIH award will help establish UCI Skin Biology Resource-based Center