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05:47:36 PM

FDA Approvals Real Time News LIVE

10/27/20 7:00 AM
Nasdaq : KALA
Kala Pharmaceuticals Announces FDA Approval of EYSUVIS(TM) for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. "The FDA approval of EYSUVIS as the first prescription
RHEA-AI
neutral
10/23/20 8:30 AM
Nasdaq : LGND
Ligand's Captisol Technology Plays Key Role in the Manufacture of Gilead's Veklury, the First FDA-Approved COVID-19 Treatment
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today highlighted the company's role in the manufacturing of Veklury(R) (remdesivir), Gilead Sciences' antiviral drug for the treatment of patients with COVID-19 requiring hospitalization. Veklury is formulated with Ligand's Captisol(R) technology. Approved yesterday by the U.S. Food and Drug Administration, Veklury is the first and only approved COVID-19 treatment in the United States. The drug is now widely available i
RHEA-AI
neutral
10/07/20 8:31 AM
Nasdaq : BMRN
BioMarin, Pioneer in Rare Disease Treatments for Phenylketonuria (PKU), Receives FDA Approval of Label Expansion to Allow Maximum Dose of 60 mg for Palynziq(R) (pegvaliase-pqpz) Injection for Treatment of Adults with PKU
BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) to increase the maximum allowable dose of 60 mg with Palynziq(R)
RHEA-AI
neutral
10/01/20 7:30 AM
Nasdaq : PLSE
Pulse Biosciences Announces FDA IDE Approval and Initiation of Sebaceous Hyperplasia Study
Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation(TM) (NPS(TM)) technology, today announced FDA Investigational Device Exemption (IDE) approval and initiation of a pivotal study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX(R) System. The data generated from this study is intended to support a 510(k) submission to expand the indication for use of the CellFX System specifica
RHEA-AI
very positive
09/28/20 4:54 PM
NYSE : PFE
U.S. FDA Approves Pfizer's XELJANZ(R) (tofacitinib) for the Treatment of Active Polyarticular Course Juvenile Idiopathic Arthritis
Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ(R) (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight.1 This approval makes XELJANZ the first and only Janus kinase (JAK) inhibitor approved in the U.S. for t
RHEA-AI
very positive
08/17/20 11:54 AM
NYSE : EBS
UPDATE -- Emergent BioSolutions Announces FDA Approval of NARCAN(R) (naloxone HCl) Nasal Spray Shelf Life Extension to 36 Months
Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the shelf life of NARCAN(R) (naloxone HCl) Nasal Spray from 24 months to 36 months. Narcan Nasal Spray was the first intranasal form of naloxone approved by FDA and Health Canada for the emergency treatment of known or suspected opioid
RHEA-AI
very positive
08/17/20 6:30 AM
NYSE : EBS
Emergent BioSolutions Announces FDA Approval of NARCAN(R) (naloxone HCl) Nasal Spray Shelf Life Extension to 36 Months
Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the shelf life of NARCAN(R) (naloxone HCl) Nasal Spray from 24 months to 36 months. Narcan Nasal Spray was the first intranasal form of naloxone approved by FDA and Health Canada for the emergency treatment of known or suspected opioid
RHEA-AI
very positive
07/06/20 4:11 PM
Nasdaq : CEMI
Chembio Announces Plans to Seek EUA Approval from FDA for Revised DPP COVID-19 IgM/IgG System and New DPP COVID-19 Antigen System
Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading global point-of-care diagnostic company focused on infectious diseases, today announced its plans to submit applications to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for a revised version of the DPP COVID-19 IgM/IgG System, a COVID-19 point-of-care serology system, and the DPP COVID-19 Antigen System, a new COVID-19 point-of-care antigen system.
RHEA-AI
very positive