BOTHELL, Wash.–(BUSINESS WIRE) January 19, 2023 — Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tukysa (tucatinib) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. — January 19, 2023 –(BUSINESS WIRE)– BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL)
FDA Approves Brenzavvy (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes The FDA approval is based on results from a clinical program that evaluated the safety and efficacy of Brenzavvy in 23 clinical trials enrolling more than 5,000 adults with type 2 diabetes mellitus. Phase 3 studies showed Brenzavvy significantly reduced hemoglobin A1c
FDA Approves Jaypirca (pirtobrutinib) for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma Jaypirca is the first BTK inhibitor of any kind specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor In the BRUIN Phase 1/2 trial, covalent BTK inhibitor pre-treated patients with relapsed or refractory MCL achieved
FDA Approves Orserdu (elacestrant) for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat. Orserdu is
November 8, 2022 Audience: Health Care Professionals November 8, 2022 — Health care professionals should be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to reverse its effects. FDA is aware of increasing reports of serious side effects from individuals exposed to fentanyl, heroin,
November 17, 2022 Audience: Consumers November 17, 2022 — Today, the U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and
November 22, 2022 Audience: Patients, Health Professionals, Pharmacy November 22, 2022 — The U.S. Food and Drug Administration (FDA) is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Our review of interim results from an
November 29, 2022 Audience: Patient, Health Professional, Pharmacy November 28, 2022 – Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are
December 21, 2022 Audience: Patient, Health Professional, Pharmacy Baltimore, Maryland, December 21, 2022 — Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has
December 27, 2022 Audience: Health Professional, Pharmacy Durham, North Carolina — December 22, 2022 — Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level. This product is being
December 27, 2022 Audience: Health Professional, Pharmacy December 22, 2022 – NEW YORK, NY., Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Vancomycin Hydrochloride Injection, USP, 1.5 g/vial Single Dose Fliptop Vial, lot 33045BA, to the user level due to two visible glass particulates observed in a single vial. If administered intravenously,
December 27, 2022 Audience: Patient, Health Professional, Pharmacy December 23, 2022 – Xiamen, Fujian, GFA Production (Xiamen) Co., Ltd. is voluntarily recalling one lot of Easy Care first aid® AfterBurn ® Cream, 0.9 g single-use packets. The single use packets are sold in boxes of 10 or packaged in certain First Aid kits. This recall
January 9, 2023 Audience: Health Professional, Pharmacy January 9, 2023 — Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored. Risk Statement: Epinephrine is a
January 27, 2023 Audience: Consumers SHELTON, Conn., January 27, 2023 – Edgewell Personal Care Company (NYSE: EPC) today expanded its voluntary nationwide recall of three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 to the consumer level as outlined in the table below. One additional batch has been added to the original
Here’s how to start your day off to the perfect morning. First, avoid impulsively checking your phone. This starts you off in a state of reactivity versus proactivity. Second, build momentum with a small productive win for the day. Make your bed and put away any clothes rather than leaving them on the floor. Third,
Young adults who survive cancer are more likely than cancer-free siblings to be lonely and to develop emotional distress, risky behaviors, and new chronic conditions as a result, findings from a large retrospective study suggest. Young cancer survivors were two times more likely to report loneliness at study baseline and follow-up. Loneliness at these times
A closer connection between those across the spectrum of life could hold some magnificent opportunities for all involved. Let’s explore the power of intergenerational living… How many people do you regularly interact with who are of a different age to you, another generation? Now take away your close friends and family, does that change things?
CNN — The number of babies born each year in the United States has been steadily dropping since the Great Recession of 2008. When the Covid-19 pandemic hit and brought another burst of uncertainty, many expected an even steeper dropoff. But a new report from the US Centers for Disease Control and Prevention says that
An ingenious innovation of a smart glove that costs less than $1 has been created with the aim to aid clinicians during birth. The study, published in the open-access journal Frontiers in Global Women’s Health, engineered the device to help healthcare staff in finding the fetal position and the force applied to the fetal head during
Everyone Is Talking About Ozempic Face – Diabetes Daily Learning Center Learning Center: LearningCenter Diabetes Daily does not provide medical advice,diagnosis or treatment.Get additional information.© 2005 – 2023 Everyday Health, Inc., a Ziff Davis company. Everyday Health is among the federally registered trademarks of Everyday Health, Inc. and may not be used by third parties
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The two national emergency declarations dealing with the COVID-19 pandemic will end May 11, President Joe Biden said Monday. Doing so will have many effects, including the end of free vaccines and health services to fight the pandemic. The public health
With nearly a quarter of us having to wait to start treatment for our mental health, we share eight ways you can look after yourself while waiting to access support The Royal College of Psychiatrists revealed that two in five (43%) adults with a mental illness feel that long waits for treatment have led to
Testing plays a crucial role in humanity’s strategy to mitigate the effects of widespread COVID-19 infection. However, given multiple options for testing and the emergence of the highly contagious Omicron variant, how do we choose which test to use? A study led by Osaka University recently found that the sensitivity of rapid antigen tests (RATs)
U.S. President Joe Biden delivers remarks on the coronavirus disease (COVID-19) before receiving a second COVID-19 booster vaccination in the Eisenhower Executive Office Building’s South Court Auditorium at the White House in Washington, U.S., March 30, 2022. Kevin Lamarque | Reuters The Biden administration plans to end the Covid public health emergency this spring, as
The Obesity Medicine Association (OMA), the clinical and educational leader in the care of patients with obesity, applauds the American Academy of Pediatrics’ (AAP) first comprehensive Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity released this month. One of the most common pediatric chronic diseases, childhood obesity is a
In an attempt to expand access to birth control under the Affordable Care Act (ACA), the Biden administration took aim at moral and religious exemptions in a proposed rule released on Monday. “Now more than ever, access to and coverage of birth control is critical as the Biden-Harris Administration works to help ensure women everywhere
Someone experiences a stroke every four seconds in the U.S., according to the Centers for Disease Control and Prevention (CDC). Learning a short acronym that can spot signs of a stroke can help save lives. A stroke generally occurs when an artery in the body is blocked or an artery ruptures in the brain. However,