united states food and drug administration Archives

bactrim antibiotic birth defects

12/04/2021 2019 Novel Coronavirus, 2019-nCoV, adverse effects, coronavirus, Coronavirus vaccine, covid 19 vaccine, drug development, experimental drug, FDA, HCoV-229E, HCoV-OC43, hospitals, Human coronavirus 229E, Human coronavirus HKU1, Human coronavirus OC43, inpatient care, patient safety, side effect, T-cell, u.s. food and drug administration, united states food and drug administration, vaccine, wuhan coronavirus

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Dozens of Americans are rolling up

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12/04/2021 Arrhythmia, biv, biventricular pacing, bradycardia, cardiac resynchronization therapy, crt, defibrillator, device safety, FDA, Heart Failure, icd, implantable cardioverter defibrillator, sudden death, u.s. food and drug administration, united states food and drug administration

The US Food and Drug Administration has declared Medtronic’s recall of seven models of defibrillating cardiac rhythm devices, due to

Health News

FDA Approves Myrbetriq to Treat Pediatric NDO

03/04/2021 adverse effe, angioneurotic edema, antigens, biologic therapy, bladder infection, Child, childhood, children, FDA, headache, hypertension, increased blood pressure, kids, oab (overactive bladder), overactive bladder (oab), pediatrics, Spinal cord injury, u.s. food and drug administration, united states food and drug administration, urinary frequency, Urinary Tract Infection, urinary tract infection (uti), UTI

The US Food and Drug Administration (FDA) has expanded the indication for Mirabegron (Myrbetriq/Myrbetriq Granules) to treat neurogenic detrusor overactivity

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FDA Warns of STAR Ankle Implant Failures

17/03/2021 clinical research, clinical studies, clinical trials, computed tomography, CT, eld, FDA, Fractures, health care technology, healthcare technology, innovations in medicine, medical innovations, pain, pain (pain management), Pain Management, patient assessment, patient evaluation, patient monitoring, Radiography, surgery, u.s. food and drug administration, united states food and drug administration, X-ray, xray

The STAR total ankle replacement breaks at a higher rate than similar devices do, and surgeons should closely monitor patients

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09/03/2021 abd, Add, ADHD, adolescent medicine, attention deficit disorder, attention deficit disorder (add), attention deficit hyperactivity disorder, Attention Deficit Hyperactivity Disorder (ADHD), brain, Child, childhood, children, ENT (ears, FDA, headache, insomnia, kids, nose, otolaryngology, pediatrics, pharyngitis, stimulant, Throat, u.s. food and drug administration, united states food and drug administration

The US Food and Drug Administration (FDA) has approved a new, once-daily oral stimulant medication for treatment of attention deficit

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FDA Clears Neuromodulation Device for Acute Migraine Pain

02/03/2021 brain, Child, childhood, children, Europe:, European, FDA, grant, headache (migraine), health care quality/access/evaluation, hospital (emergency services), interns, internship, kids, migraine, migraine headache, neuromodulators, pain, pain (pain management), Pain Management, pediatrics, social determinants of health, u.s. food and drug administration, united states food and drug administration

The US Food and Drug Administration (FDA) has cleared the first noninvasive multichannel brain neuromodulation system to treat acute migraine

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Peanut Sublingual Immunotherapy Feasible and Effective in Toddlers

28/02/2021 adverse effects, allergens, Allergy, allergy to peanuts, Asthma, asthmatic, biologic therapy, chil, Child, childhood, children, clinical research, clinical studies, clinical trials, FDA, Food Allergy, immunotherapy, itch, kids, patient safety, peanut allergy, peanut anaphylaxis, pediatrics, pruritis, pruritus, side effects, tolerance, u.s. food and drug administration, united states food and drug administration

Sublingual immunotherapy for the treatment of peanut allergy is safe and effective, even in children as young as age 1

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Janssen/J&J COVID-19 Vaccine Cuts Transmission, New Data Show

24/02/2021 2019 Novel Coronavirus, 2019-nCoV, coronavirus, Coronavirus vaccine, covid 19 vaccine, drug development, experimental drug, FDA, HCoV-229E, HCoV-OC43, health care quality/access/evalua, Human coronavirus 229E, Human coronavirus HKU1, Human coronavirus OC43, immunizations, patient safety, u.s. food and drug administration, united states food and drug administration, Vaccination, vaccine, wuhan coronavirus

Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. New findings suggest the Janssen/Johnson and Johnson COVID-19 vaccine

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Bladder Cancer Indication Withdrawn for Durvalumab

23/02/2021 biologic therapy, bladder, Bladder Cancer, cancer, carcinoma, chemotherapy, clinical research, clinical studies, clinical trials, FDA, grant, immunotherapy, malignant bladder neoplasm, malignant neoplasia, neoadjuvant, u.s. food and drug administration, united states food and drug administration

After failing to improve overall survival in unresectable metastatic bladder cancer in a phase 3 trial, this indication will be

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Task Force Tackles FDA Lamotrigine Cardiac Risk Warning

23/02/2021 Arrhythmia, distributed seizure, ecg, ekg, electrocardiogram, electrophysiology, epilepsy, FDA, focal onset epilepsy, frontal lobe epilepsy, generalized epilepsy, generalized seizure, hea, heart, localization-related epilepsy, localized seizure, myoclonic epilepsy, partial epilepsy, seizure, seizure disorder, simple partial seizure, u.s. food and drug administration, united states food and drug administration

A joint task force of the American Epilepsy Society (AES) and International League Against Epilepsy (ILAE) has issued an advisory

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