Drugs

FDA Approves Yuflyma (adalimumab-aaty), a Biosimilar to Humira JERSEY CITY, N.J.–(BUSINESS WIRE) May 24, 2023 –Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar. The FDA granted approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic

FDA Approves Inpefa (sotagliflozin) for the Treatment of Heart Failure THE WOODLANDS, Texas, May 26, 2023 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Inpefa™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent

FDA Approves Paxlovid (nirmatrelvir tablets and ritonavir tablets) for Adult Patients at High Risk of Progression to Severe COVID-19 NEW YORK–(BUSINESS WIRE) May 25, 2023 — Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults

INDIANAPOLIS, April 13, 2023 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of ulcerative colitis (UC). In the letter, the FDA cited issues related to the proposed manufacturing of mirikizumab, with

FDA Approves Xacduro (sulbactam and durlobactam) for the Treatment of Serious Infections Caused by Acinetobacter WALTHAM, Mass.–(BUSINESS WIRE)–May 23, 2023– Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that the U.S. Food and Drug Administration (FDA) approved Xacduro® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in patients 18

Image by Robin Higgins @Pixabay In a recent clinical trial, scientists have discovered a potential new drug-free option for migraine prevention called remote electrical neuromodulation (REN).1  Migraines affect about 14% of the global population or more than one billion people worldwide.2 Unfortunately, there may be more people suffering from migraines than we realize because they

Treatment for: Anemia, Sickle Cell bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events SOMERVILLE, Mass.–(BUSINESS WIRE)–Apr. 24, 2023– bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA)

FDA Approves Opvee (nalmefene hydrochloride) Prescription Nasal Spray to Reverse Opioid Overdose May 22, 2023 — Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This is the

FDA Approves Epkinly (epcoritamab-bysp) Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) NORTH CHICAGO, Ill., May 19, 2023 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved Epkinly (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the

News FDA Alerts Novis PR LLC Issues Voluntary Recall of G-Supress DX Pediatric Drops Due to Incorrect Packaging May 19, 2023 Audience: Consumer May 19, 2023 – San Juan, PR, Novis PR LLC is voluntarily recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops to the consumer level. Some cartons of the product have

Image by Irfan Ullah @Pixabay Guillain-Barré syndrome is an autoimmune disorder where the body’s immune system attacks healthy tissues.1 In Guillain-Barré syndrome (GBS), the immune system attacks the peripheral nervous system. The peripheral nervous system controls the information sent from organs and other parts of your body back to your brain, and vice versa, like

FDA Approves Skinvive by Juvéderm (hyaluronic acid) Microdroplet Injection to Improve Skin Smoothness of the Cheeks IRVINE, Calif., May 15, 2023 /PRNewswire/ — Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of Skinvive™ by Juvéderm® to improve skin smoothness of the cheeks in adults over the age of 21.1 Skinvive™

April 26, 2023 Audience: Wholesalers, Retailers, Manufacturers, Medical Facilities, Repackagers, Consumers April 26, 2023 – Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn

NASHVILLE, Tenn., May 15, 2023 /PRNewswire/ — Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor, an intravenously delivered formulation of ibuprofen, to now include use in infants. The non-narcotic agent may now be administered for the treatment of

Image by Choktiniti Khongchum @Pexels What we know about endocrine disruptor chemicals Endocrine disruptors are chemicals present in many everyday products, including food. They can mimic hormones and alter their activity, leading to several biological effects. We know these chemicals cause harmful effects in animals, but we don’t know much about their effects in humans.1 Understanding the

May 11, 2023 Audience: Health Care Professionals, Patients, Caregivers What safety concern is FDA announcing? To address continuing concerns of misuse, abuse, addiction, and overdose of prescription stimulants, the U.S. Food and Drug Administration (FDA) is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the

Generic name: tenapanorTreatment for: Hyperphosphatemia of Renal Failure Ardelyx Resubmits New Drug Application to U.S. Food and Drug Administration for Xphozah (tenapanor) WALTHAM, Mass., April 18, 2023 (GLOBE NEWSWIRE) — Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs,

FDA Approves Veozah (fezolinetant) for the Treatment of Vasomotor Symptoms Due to Menopause TOKYO, May 13 2023 – Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Veozah (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12.

April 27, 2023 Audience: Consumers April 27, 2023 — TruVision Health LLC is recalling the dietary supplement products listed below because they contain the unapproved dietary ingredients hordenine and/or octodrine/DMHA (1,5-Dimethylhexylamine). Hordenine is possibly unsafe when taken by mouth and might cause stimulating side effects such as rapid heart rate, high blood pressure, jitteriness, nervousness,

FDA Approves Arexvy (respiratory syncytial virus vaccine, adjuvanted) Respiratory Syncytial Virus (RSV) Vaccine for Older Adults May 3, 2023 — GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial

April 27, 2023 Audience: Health Professional, Pharmacy, Consumer April 27, 2023, Parsippany, NJ — Teva Pharmaceuticals USA, has initiated a voluntary nationwide recall of specific lots of various strengths of Fentanyl Buccal Tablets CII to the Consumer Level. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma Inc. under Mayne’s label. This

FDA Approves Mydcombi (tropicamide and phenylephrine hydrochloride) Ophthalmic Spray for Inducing Mydriasis NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) — Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for

News FDA Alerts FDA Warns Consumers to Not Purchase or Use Nose Slap and Soul Slap Products Marketed for Alertness and Energy Boosting May 1, 2023 Audience: Consumers May 1, 2023 — FDA is warning consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness

FDA Approves Elfabrio (pegunigalsidase alfa-iwxj) for the Treatment of Adult Patients with Fabry Disease BOSTON and CARMIEL, Israel, May 10, 2023 /PRNewswire/ — Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical

News FDA Alerts Family Dollar is Initiating a Voluntary Recall of Certain Over-the-Counter Drug Products Because the Products Have Been Stored Outside of Labeled Temperature Requirements May 4, 2023 Audience: Consumers May 4, 2023 — Family Dollar is initiating a voluntary retail level product recall of certain over-the-counter drug products regulated by the U.S. Food

Image by Andrea Piacqquadio @Pexels No typical presentation exists, but a new blood test could detect endometriosis. Endometriosis is a disease affecting millions of women. Endometriosis and its symptoms are varied and cause some women intense pain and problems conceiving children.1  Current standards require surgery for a final diagnosis of this disease. Doctors have been

Photo by Natalyia Vaitkevich @Pexels What is HPV? The human papillomavirus (HPV) is a direct contact sexually-transmitted agent. There are roughly 150 known types of HPV.1 Between 2012 and 2016, an estimated 34,800 HPV-related cancers occurred annually in the United States.1  The human papillomavirus can cause warts in the genital area, respiratory tract, and even

Photo by Kenny Eliason @Unsplash Obesity rates are a massive global health problem.1 Unfortunately, there are few medications available to manage obesity.1 Those struggling with obesity face health conditions like type 2 diabetes, cardiovascular disease, fatty liver disease, and a shortened life expectancy.1 Because so many people live with obesity and the disease’s collateral conditions, the