20/20 GENESYSTEMS: To Provide Newly FDA Authorized COVID-19 Antibody Blood Test
Lab Testing, in Combination with AI-Building Data Collection, Expected to Improve Predictive Power of Antibodies in Pandemic Response
Lab Testing, in Combination with AI-Building Data Collection, Expected to Improve Predictive Power of Antibodies in Pandemic Response
The following statement is attributed to Mindy Brashears, Ph.D., USDA Under Secretary for Food Safety, and Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response
Patch now authorised in the USA for emergency use for patients undergoing treatment for COVID-19
Marking, Coding, and Packaging Products are a Key Part of the Critical Supply Chain Overhaul
U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
COVID-19 Clinical Real-World Data Being Utilized to Monitor for Potential Drug Shortages
First and only sublingual therapy approved for the on-demand treatment of Parkinson’s disease OFF episodes
Long-Term Results from the Phase 3 ALTA 1L Trial Established ALUNBRIG as a Superior First-Line Treatment Compared to Crizotinib for People with ALK+ Metastatic NSCLC, Including those with Brain Metastases
The U.S. Food and Drug Administration granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older.
The U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients.
CytRx Corporation (OTCQB: CYTR), a biopharmaceutical research and development company specializing principally in oncology and neurodegenerative diseases, today highlighted that Orphayzme A/S announced they have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the development of arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS).
In the pivotal trial, more than twice as many children achieved clear or almost clear skin and more than four times achieved itch reduction with Dupixent plus topical corticosteroids (TCS) compared to TCS alone
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced that the U.S. Food and Drug Administration (FDA) has approved VESIcare LS™ (solifenacin succinate) oral suspension for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older.
Beckman Coulter Life Sciences today announced RNAdvance Viral XP has been added to the list of acceptable extraction methods for use in the Centers for Disease Control's EUA-authorized COVID-19 test referenced in the FDA's FAQ on testing for SARS-CoV-2.
Approval Marks Significant Advance Towards a More Definitive Assessment of Alzheimer’s Based on Brain Imaging
The U.S. Food and Drug Administration granted approval to Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.
ZILXI™ Now Approved for Inflammatory Lesions of Rosacea in Adults
CYRAMZA, in combination with erlotinib, now approved for the treatment of people with untreated metastatic non-small cell lung cancer (NSCLC) with certain activating EGFR mutations, based on the positive global Phase 3 RELAY study
The FDA has taken additional action to help ensure widespread access to hand sanitizers during the COVID-19 public health emergency.
The U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.