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 | 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 | 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...
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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 | 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.
VOQUEZNA® 20mg and 10mg Bottle
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 | 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 | 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...
LOQTORZI™ (toripalimab-tpzi)
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 | 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...
Maxigesic IV product 2
Hyloris announces U.S. FDA Approval of Maxigesic® IV
October 18, 2023 01:00 ET | 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 ...
Maxigesic IV product 2
Hyloris annonce l’approbation de Maxigesic® IV par la FDA Américaine
October 18, 2023 01:00 ET | 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...
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FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for Treatment of Psoriasis in Children Ages 6 to 11
October 06, 2023 08:00 ET | 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 | 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....