Emergent BioSolutions Receives U.S. FDA Approval of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use
July 20, 2023 18:03 ET
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Emergent BioSolutions
Emergent has been delivering CYFENDUS™ vaccine to the U.S. Department of Health and Human Services since 2019, under pre-Emergency Use Authorization status, and will continue to work with the U.S....
BioCorRx Submits Fast Track Application to FDA for BICX104, an Implantable Biodegradable Naltrexone Pellet for The Treatment of Opioid Use Disorder
July 18, 2023 08:30 ET
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BioCorRx Inc
ANAHEIM, CA, July 18, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – BioCorRx Inc. (OTCQB: BICX) (the “Company”), a developer and provider of innovative treatment programs for substance abuse and...
FDA Approves Groundbreaking New Product Utilizing Berkshire Sterile Excipient Gel to Treat 'Butterfly Children'
May 25, 2023 11:10 ET
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Berkshire Sterile Manufacturing
Lee, MA, May 25, 2023 (GLOBE NEWSWIRE) -- On May 19, 2023, Krystal Biotech, a client of Berkshire Sterile Manufacturing (BSM), received FDA approval for VYJUVEK™, the first-ever topical gene therapy...
Upon FDA approval, Advanced Medical Balloons launches innovative hygh-tec catheter system for ICU stool drainage in U.S. market
May 04, 2023 08:00 ET
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Advanced Medical Balloons GmbH
Creative Balloons operates under new name Advanced Medical Balloons (AMB)AMB’s microscopically thin polyurethane (PUR) balloon catheter systems address indications in intensive care1st product from...
Travere Therapeutics Announces FDA Accelerated Approval of FILSPARI™ (sparsentan), the First and Only Non-immunosuppressive Therapy for the Reduction of Proteinuria in IgA Nephropathy
February 17, 2023 16:04 ET
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Travere Therapeutics, Inc.
First single molecule Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved for use in patients withIgA nephropathy (IgAN)Interim results from the ongoing Phase 3 PROTECT head-to-head trial...
SeaStar Medical Receives FDA Approval to Begin Study with Selective Cytopheretic Device to Reduce Hyperinflammation in Adults with Acute Kidney Injury
February 09, 2023 08:19 ET
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SeaStar Medical Holding Corporation
Patient enrollment in pivotal clinical study expected to begin in March DENVER, Feb. 09, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical (Nasdaq: ICU), a medical device company developing proprietary...
Recent FDA Approval of Advanced Treatment for Patients with Metastatic Non Small-Cell Lung Cancer (NSCLC) Demonstrates Importance of Participation in Clinical Trials
December 06, 2022 15:41 ET
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Florida Cancer Specialists & Research Institute
Ft. Myers, Fla., Dec. 06, 2022 (GLOBE NEWSWIRE) -- A clinical study conducted with participation by Florida Cancer Specialists & Research Institute, LLC (FCS) has led to FDA approval of a new...
WHILL Power Chairs Announces Partnership With Stealth Products
October 24, 2022 12:00 ET
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WHILL Inc.
SAN FRANCISCO, Oct. 24, 2022 (GLOBE NEWSWIRE) -- WHILL, Inc., award-winning provider of electric mobility chairs, and Stealth Products LLC, announced a new partnership whereby seating and...
Berkshire Sterile client receives FDA approval on product indicated to reduce risk of hearing loss for childhood cancer patients
September 29, 2022 11:00 ET
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Berkshire Sterile Manufacturing
Lee, MA, Sept. 29, 2022 (GLOBE NEWSWIRE) -- On September 21st, 2022, Berkshire Sterile Manufacturing’s (BSM) client, Fennec Pharmaceuticals Inc., received FDA approval of their drug product, PEDMARK...
FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older
July 29, 2022 16:05 ET
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Arcutis Biotherapeutics, Inc.
First and only topical PDE4 inhibitor approved for the treatment of plaque psoriasis, including intertriginous psoriasis Approved for once-daily treatment in mild, moderate, and severe plaque...