Phathom Pharmaceuticals Announces FDA Approval of Reformulated Vonoprazan Tablets for VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA® DUAL PAK® (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults
30 oct. 2023 08h00 HE
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Phathom Pharmaceuticals
Planning for a December 2023 U.S. launch for H. pylori, together with the U.S. launch of vonoprazan for Erosive GERD, if approved FLORHAM PARK, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Phathom...
Coherus and Junshi Biosciences Announce FDA Approval of LOQTORZI™ (toripalimab-tpzi) in All Lines of Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
27 oct. 2023 15h07 HE
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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
18 oct. 2023 01h00 HE
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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
18 oct. 2023 01h00 HE
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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
06 oct. 2023 08h00 HE
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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
20 juil. 2023 18h03 HE
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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
18 juil. 2023 08h30 HE
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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'
25 mai 2023 11h10 HE
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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
04 mai 2023 08h00 HE
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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
17 févr. 2023 16h04 HE
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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...