Coherus and Junshi Biosciences Announce FDA Approval of LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
October 27, 2023 15:07 ET
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Coherus BioSciences, Inc.
– LOQTORZI is the first and only FDA-approved treatment for NPC – – Indicated in combination with chemotherapy for 1st line treatment and as monotherapy for patients with disease progression on or...
Hyloris annonce l’approbation de Maxigesic® IV par la FDA Américaine
October 18, 2023 01:00 ET
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Hyloris Pharmaceuticals SA
Le puissant analgésique non opioïde Maxigesic® IV sera commercialisé aux États-Unis sous le nom de Combogesic® IVLes premières ventes aux États-Unis début de 2024 donneront lieu à un paiement d'étape...
Hyloris announces U.S. FDA Approval of Maxigesic® IV
October 18, 2023 01:00 ET
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Hyloris Pharmaceuticals SA
Maxigesic® IV, a potent non-opioid painkiller, to be marketed in the U.S. under the tradename Combogesic® IVFirst U.S. sales expected in early 2024, triggering a milestone payment of USD 2,1 million ...
FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11
October 06, 2023 08:00 ET
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Arcutis Biotherapeutics, Inc.
Arcutis today announced the FDA has approved an sNDA to expand the indication of ZORYVE (roflumilast) cream 0.3%.
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...