Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML)
16 janv. 2024 13h30 HE
|
Hyloris Pharmaceuticals SA
Orphan Drug Designation Granted to PTX-252 by U.S. FDA for the Treatment of Acute Myeloid Leukaemia (AML) PTX-252 (previously referenced as a Plecoid™Agent) is a novel molecular entity developed in...
Coherus Announces FDA Approval of UDENYCA ONBODY™, a Novel and Proprietary State-of-the-Art Delivery System for pegfilgrastim-cbqv
26 déc. 2023 16h01 HE
|
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
15 déc. 2023 17h11 HE
|
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
13 déc. 2023 07h25 HE
|
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
04 déc. 2023 01h00 HE
|
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
04 déc. 2023 01h00 HE
|
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
28 nov. 2023 08h00 HE
|
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
21 nov. 2023 09h46 HE
|
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
16 nov. 2023 10h34 HE
|
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
01 nov. 2023 17h00 HE
|
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...