FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia Morristown, N.J. March 31, 2021 — Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult
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PARIS, March 31, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. “In the Phase 3 IKEMA study, the addition
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FDA Approves Qelbree (viloxazine) for the Treatment of ADHD ROCKVILLE, Md., April 02, 2021 (GLOBE NEWSWIRE) – Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity
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FOSTER CITY, Calif.–(BUSINESS WIRE)–Apr. 7, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval to Trodelvy® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The
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South San Francisco, CA — April 12, 2021 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only
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March 17, 2021 Audience: Consumers March 17, 2021 — Raleigh, North Carolina, PNHC, LLC, d/b/a Heal the World, is voluntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers to the consumer level. The products are being recalled because they resemble 9.6ounce water bottles. The recall does not affect
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March 24, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 24, 2021 — Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one
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March 24, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 24, 2021 — FDA Safety Communication Purpose: To inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) to include a new warning about the risk for Guillain-Barré Syndrome (GBS)
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March 25, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 25, 2021  — The U.S. Food and Drug Administration (FDA) is warning that the abuse and misuse of the overthe-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Some of these complications, which include fast or abnormal
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March 25, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 25, 2021 — Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials. Administration of crystalized Acyclovir Sodium Injection, 50
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News FDA Alerts Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and Tadalafil March 26, 2021 Audience: Consumer March 26, 2021 — Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling all lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA
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March 31, 2021 Audience: Patient, Health Professional, Pharmacy, Neurology, Cardiology, Psychiatry ISSUE: An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine). FDA wants to evaluate whether other medicines in the same
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March 31, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy March 31, 2021 Weston, Florida – Apotex Corp is voluntarily recalling three (3) lots of Guanfacine Extended-Release Tablets 2mg to the consumer level due to trace amounts of Quetiapine Fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included
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April 2, 2021 Audience: Consumer, Patient, Health Professional, Pharmacy April 02, 2021 — Libertyville, IL, A-S Medication Solutions, LLM (ASM) is voluntarily recalling 198,350 bottles of Acetaminophen Extra Strength 500 mg Tablets, 100 ct. bottles (NDC# 50090-5350-0) contained in Health Essentials Kits distributed by Humana to its members. See the photo below. This recall is
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Posted on March 25, 2021 by Ajla Bedzetovic Diane worried about leaving the hospital. She’d been admitted, again, for losing consciousness due to a health issue that caused her blood oxygen level to drop.   “It’s scary to wake up on the floor and not realize what happened,” she said. “Since I live alone, my family
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A Centers for Disease Control and Prevention panel on Wednesday decided to postpone a decision on Johnson & Johnson’s Covid-19 vaccine while it investigates cases of six women developing a rare but potentially life-threatening blood-clotting disorder that left one dead and one in critical condition. The CDC’s Advisory Committee on Immunization Practices met a day after
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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, left, speaks with Dr. David Kessler, Chief Science Officer of the White House COVID-19 response team, before a Senate Health, Education, Labor and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021 in Washington, DC. Susan
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Dr. Atul Gawande said he “thinks there is something distinct going on here” when it comes to blood clotting and Johnson & Johnson‘s single-dose Covid-19 vaccine. “We have an unusual kind of blood clotting syndrome, very specific to these vaccines, in the younger age group women, and it’s not like the other kinds of cases
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Maldives will soon offer visitors vaccinations on arrival as part of its three-pronged initiative aimed at reviving the country’s hard hit travel sector, according to its tourism minister. The “3V” strategy, which encourages tourists to “visit, vaccinate, and vacation,” will provide a “more convenient” way to visit the country, Abdulla Mausoom told CNBC on Wednesday.
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With summer around the corner, a project shows how implementing an evidence-based mindfulness program in a summer camp setting decreases emotional distress in school age children and empowers campers and counselors alike – enhancing camper-counselor relationships. Mindfulness – a state of consciousness that fosters awareness – has the potential to help regulate emotions and behaviors.
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