Application supported by positive results from two global Phase 3 studies in people with CF ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations
Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceuticals Inc, USA, which is a wholly owned subsidiary of Mumbai-based Sun Pharmaceutical Industries Ltd. (Sun Pharma), has launched XELPROS Xpress™ - an access program for patients prescribed XELPROS™ (latanoprost ophthalmic emulsion) 0.005%.
Paragon Biosciences LLC — the Chicago-based life science innovator that invests in, builds, and advises bioscience companies — is announcing the launch of its seventh portfolio company, Qlarity Imaging LLC, which was founded to harness the value of artificial intelligence (AI) to improve medical outcomes.
The pending submission is supported by data from two randomized controlled clinical trials of more than 1,400 patients
Allergan continues advancement in eye care innovation, developing specialized treatments for patients
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved RECARBRIO™ (imipenem, cilastatin, and relebactam) for injection, 1.25 grams, a new combination antibacterial. RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology ("3LT"), announces that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its FX 635 low level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.
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The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
Submission Based on Pivotal Phase 2 Trial Results Recently Presented at Annual Meeting of American Society of Clinical Oncology
The First Digital Maintenance Asthma Inhaler Therapy with Integrated Sensors Joins Teva’s Digital Rescue Inhaler Therapy to Provide Patients with Technology to Track Treatment Use
Coronary artery disease (CAD) is an important public health issue-- a disease that affects 16.5 million Americans
Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biopharmaceutical company which specializes in the development of novel therapies to restore, treat and prevent inner ear diseases such as hearing loss, tinnitus and vertigo, announces that it has received the Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.
Alinity™ s System will screen the U.S. blood and plasma supply faster and more efficiently while maintaining highest levels of accuracy
La Roche-Posay Launches Effaclar Adapalene Gel 0.1% Acne Treatment and My Skin Track PoreScan
DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, announced the first Utahns have been treated in its nationwide clinical study of IDCT, a locally developed injectable disc cell therapy for degenerative disc disease (DDD).
SNDX-5613 is a potent, highly selective, oral inhibitor of the interaction of Menin with the Mixed Lineage Leukemia (MLL) protein
All Criteria for the Response-Based Endpoint Now Finalized
Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia (amlodipine) Oral Suspension, 1 mg/mL, the first and only FDA-approved amlodipine oral suspension. Katerzia is indicated for the treatment of hypertension (high blood pressure) in adults and pediatric patients 6 years of age and older and coronary artery disease in adults.
This week, ConTIPI Medical Ltd. received US Food and Drug Administration (FDA) approval to market its new product, the first of its kind, designed to treat pelvic prolapse in women (such as the uterus and bladder).
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for KEYTRUDA, Merck’s anti-PD-1 therapy, to include an every-six-weeks (Q6W) dosing schedule option.