IPIX, OTC #Cancer #FDA Innovation Pharmaceuticals Visits BeaMed; New StingRay Laser System for Epilepsy and Brain Tumors Moving Toward FDA Submission February 23, 2023 08:00 EST WAKEFIELD, MA, Feb. 23, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company and minority stakeholder in BT BeaMed Technologies (“BeaMed”), is pleased to inform shareholders that development of the BeaMed StingRay Laser System (the “StingRay System”) is progressing smoothly and No Comments
NYSE, PFE #FDA Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance February 22, 2023 06:45 EST NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma No Comments
NYSE, TFX #Expansion #FDA Teleflex Expands Interventional Cardiology Portfolio with Two New FDA-Cleared Catheter Devices for Use in Complex Percutaneous Coronary Interventions (PCI) February 22, 2023 06:30 EST WAYNE, Pa., Feb. 22, 2023 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced key milestones in the release of two new catheters: the U.S. Food and Drug Administration (FDA) 510(k) clearance of the Triumph™ Catheter, and the first clinical use of No Comments
ARQT, NASDAQ #FDA #Skin #Trending News Arcutis Submits Topical Roflumilast Foam 0.3% New Drug Application to the FDA for the Treatment of Seborrheic Dermatitis in Adults and Adolescents February 21, 2023 08:00 EST Seborrheic dermatitis is an inflammatory skin disease affecting more than 10 million individuals in the United States If approved, roflumilast foam would be the first topical drug for seborrheic dermatitis with a new mechanism of action in over two decades In a pivotal Phase 3 trial, 80% of individuals No Comments
CINC, NASDAQ #Event #FDA #Phase 2 CinCor Pharma Announces Receipt of Minutes from End-of-Phase 2 Meeting with the U.S. Food and Drug Administration on Planned Phase 3 Program of Baxdrostat February 21, 2023 08:00 EST WALTHAM, Mass., Feb. 21, 2023 (GLOBE NEWSWIRE) — CinCor Pharma, Inc. (“CinCor” or the “Company”) announced today completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) on the anticipated Phase 3 program for baxdrostat in hypertension. Baxdrostat is a once daily potentially first-in-class, highly No Comments
AKBA, NASDAQ #FDA #Liver #Trending News Akebia Therapeutics Received Interim Response from the FDA to Appeal for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease February 21, 2023 06:30 EST CAMBRIDGE, Mass., Feb. 21, 2023 /PRNewswire/ — Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company received a second interim response from the U.S. Food and Drug Administration to its Formal Dispute No Comments
INBS, NASDAQ #FDA #Trending News Intelligent Bio Solutions Inc. files FDA 513(g) regulatory submission for Intelligent Fingerprinting Drug Screening Cartridge February 16, 2023 08:30 EST – 513(g) submission will allow Intelligent Bio Solutions Inc. to determine the most suitable FDA regulatory pathway for its Intelligent Fingerprinting Drug Screening Cartridge, as the next step in its expansion strategy into the U.S. – – Intelligent Fingerprinting Drug Screening Cartridge quickly detects the presence of four drugs No Comments
EBS, NYSE #FDA #NASA #Trending News Emergent BioSolutions Reports FDA Advisory Committees’ Unanimous Vote in Favor of NARCAN® (naloxone HCI) Nasal Spray for Over-the-Counter Use February 15, 2023 17:19 EST If approved by the FDA, NARCAN Nasal Spray will be the first 4 mg naloxone nasal spray switched from prescription status to over-the-counter use GAITHERSBURG, Md., Feb. 15, 2023 (GLOBE NEWSWIRE) — Today, Emergent BioSolutions Inc. (NYSE:EBS) announced the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee No Comments
ENTX, NASDAQ #Event #FDA #Phase 3 #Trending News Entera Bio Announces FDA’s Acceptance of a Type D Meeting Review to Affirm Design of the Pivotal, Phase 3 Protocol for EB613 PTH Mini Tablets, as the First Oral Osteoanabolic Treatment of Post-Menopausal Osteoporosis February 15, 2023 10:00 EST Type D meeting protocol submission builds on concurrence reached with FDA following successful Type C meeting and supports potential Phase 3 initiation in H2 2023 JERUSALEM, Feb. 15, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered No Comments
NASDAQ, RDHL #Event #FDA #Syndromes #Trending News RedHill Biopharma Announces Positive FDA Meeting Regarding Opaganib for Acute Nuclear Radiation Syndrome February 15, 2023 07:00 EST FDA provided guidance on opaganib’s regulatory pathway under the Animal Rule for Acute Radiation Syndrome (ARS) The FDA’s Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible Opaganib is an No Comments
Tactile Systems Technology, Inc. Announces Pricing of $32.5 Million Public Offering of Common Stock 02/23/2023
Columbia Banking System Set to Join S&P MidCap 400; Verra Mobility to Join S&P SmallCap 600 02/23/2023
