First OTC Preservative-Free Eye Drop Approved for the Treatment of Itchy Eyes Associated with Allergies. Provides Up to 12 Hours of Eye Itch Relief
Neurophth Therapeutics, Inc., (hereinafter referred to as "Neurophth") today announced that its leading candidate, NR082 (rAAV2-ND4, NFS-01 project), was granted an orphan drug designation (ODD) by the U.S. FDA for the treatment of Leber's Hereditary Optic Neuropathy associated with ND4 mutation.
Consumers for Dental Choice issued the following announcement on September 24.A broad array of consumer, medical, parents, and environmental groups are lauding a new safety communication from the U.S.
On September 24, XiangXue Life Sciences (XLifeSc), a partner of GenScript ProBio, announces FDA allowance of its IND application for TCR-T program (TCRT-ESO-A2). GenScript ProBio extends congratulations on this.
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and B. Braun Medical Inc., a global market leader in regional anesthesia and pain management, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Onvision®, a breakthrough ultrasound guidance solution for real-time needle tip tracking.
Valencia Technologies Corporation ("Valencia"), a private medical device company, today announced the filing of its pre-market approval (PMA) application of its eCoin® Peripheral Neurostimulator System for overactive bladder with the Food and Drug Administration (FDA). e
Following completion of the FDA review process at US Customs, Kiil is released for distribution
Romark, a research-based pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the field of infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved the company's manufacturing facility in Manati, Puerto Rico for the production of ALINIA® (nitazoxanide) tablets, 500 mg and ALINIA® (nitazoxanide) for Oral Suspension, 100 mg/5mL in the U.S. market.
Indication expansion follows recent clearance for use in fractures of the pelvis, the clavicle, and small bones of the hand and foot
Fully transparent, anti-fog masks available to help healthcare providers and essential workers to protect themselves, communicate better, and ease confusion
FDA has cleared MagVenture TMS Therapy® for adjunct treatment of Obsessive-Compulsive Disorder (OCD).
The U.S. Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
As part of the company's Software Upgrades for Life program, the upgrade will be deployed to all installed U.S. molecular imaging systems at no additional cost to customers.
The U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute pain in adults, where the pain is severe enough to require an intravenous opioid and for whom alternative treatments are inadequate.
The U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC).
Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee"), announced today that it has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for Camcevi™ 42mg (FP-001 LMIS 50mg), a ready-to-use 6-month depot formulation of leuprolide mesylate.
Plans to Initiate Phase 1 Clinical Trial This Year