Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
December 26, 2023 16:01 ET
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Coherus BioSciences, Inc.
– Innovative design enables five-minute pegfilgrastim delivery time – – Unique, automatic, retractable needle mechanism engineered to maximize safety and comfort for cancer patients receiving...
FDA Approves Arcutis’ ZORYVE® (roflumilast) Topical Foam, 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
December 15, 2023 17:11 ET
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Arcutis Biotherapeutics, Inc.
ZORYVE foam represents a highly effective, safe, well-tolerated, once-daily steroid-free foam for use on all affected areas of the body, including hair-bearing areas, with no limitations on duration...
Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide
December 13, 2023 07:25 ET
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Arch Biopartners
TORONTO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today it has submitted a Clinical Trial Application to...
Hyloris annonce l'approbation du Gel Podofilox par la FDA américaine
December 04, 2023 01:00 ET
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Hyloris Pharmaceuticals SA
Hyloris annonce l'approbation du Gel Podofilox par la FDA américaine - Produit référencé comme HY-016, ciblant les condylomes génitaux et périanaux - Lancement de la commercialisation aux États-Unis...
Hyloris announces US FDA approval for Podofilox Gel
December 04, 2023 01:00 ET
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Hyloris Pharmaceuticals SA
Hyloris announces US FDA approval for Podofilox Gel Product previously referenced as HY-016, targeting genital and perianal wartsUS Commercialization by partner Padagis to start in December...
Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn
November 28, 2023 08:00 ET
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Phathom Pharmaceuticals
VOQUEZNA, the first and only FDA-approved potassium-competitive acid blocker (PCAB), is now available at major retail pharmacies and through BlinkRx.
Immix Biopharma Announces FDA Approval of IND Application for CAR-T NXC-201, Enabling U.S. Patient Dosing
November 21, 2023 09:46 ET
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Immix Biopharma, Inc.
NEXICART-2 to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to U.S. sites based on IND clearance72 patients previously dosed with NXC-201 ex-U.S.First CAR-T program for light-chain...
OUTLOOK THERAPEUTICS INVESTOR ALERT: Kaplan Fox & Kilsheimer LLP Notifies Outlook Therapeutics Investors of a Class Action Lawsuit and Upcoming Deadline
November 16, 2023 10:34 ET
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Kaplan Fox & Kilsheimer LLP
Kaplan Fox reminds investors that a complaint has been filed on behalf of investors that purchased or otherwise acquired Outlook Therapeutics.
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA® (vonoprazan) Tablets for the Treatment of Erosive GERD and Relief of Heartburn Associated with Erosive GERD in Adults
November 01, 2023 17:00 ET
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Phathom Pharmaceuticals
FDA approval marks the first major innovation to the U.S. Erosive GERD market in over 30 yearsVOQUEZNA® met the primary endpoints and key secondary superiority endpoints in the pivotal Phase 3...
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
October 30, 2023 08:00 ET
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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...