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Analysts point to a missed secondary endpoint and cardiovascular risks that may delay FDA approval as possible reasons for the unexpected drop in Karuna's stock following the data reveal.
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In a double data drop Thursday, AbbVie touted two clinical trial wins, for Skyrizi in ulcerative colitis and Rinvoq in systemic lupus erythematosus.
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Upstaza is the first targeted therapy for aromatic L-amino acid decarboxylase (AADC) deficiency. PTC expects to submit a Biologics License Application to the FDA in the first half of 2023.
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Sponsored: Inspirational Space Sparks Scientific Innovation at the First Life Sciences Building i...
3/24/2023
Real estate development firm Sterling Bay launches life sciences division starting with Lincoln Yards, a 320,000 square foot site on the Chicago River. -
Iovance Biotherapeutics Completes Biologics License Application (BLA) Submission for Lifileucel in Advanced Melanoma
3/24/2023
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel.
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Greenbrook TMS Announces US$8.25 Million Equity and Debt Financings
3/24/2023
Greenbrook TMS Inc. today announced that it has (i) completed a non-brokered private placement of common shares of the Company for aggregate gross proceeds of approximately US$6.25 million.
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BioSig Announces New Advisory Board Member Lorraine Spurge
3/24/2023
BioSig Technologies, Inc. today announced the appointment of Lorraine Spurge, entrepreneur and financier, to its Advisory Board.
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FDA Takes Additional Steps to Improve Nutrition, Reduce Disease with Expanded Use of Salt Substitutes to Help Lower Sodium Intake
3/24/2023
Today, the U.S. Food and Drug Administration proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes.
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Spectral Medical Announces Fourth Quarter and Fiscal 2022 Results and Provides Corporate Update
3/24/2023
Spectral Medical Inc. today announced its financial results for the fourth quarter and for the year ended December 31, 2022 and provided a corporate update.
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HDT Bio Publishes Peer-Reviewed Preclinical Study Demonstrating Robust Immunological Response in Mothers and Newborns Following repRNA/LION™ Vaccination
3/24/2023
HDT Bio Corp. today announced the peer-reviewed publication of preclinical data demonstrating that its self-amplifying replicon mRNA (repRNA) vaccines, delivered via HDT Bio's proprietary LION nanoparticle formulation, provide robust maternal and neonatal immunogenicity against two pathogens with high mother-to-child transmission risk: HIV-1 and Zika virus (ZIKV).
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Impel Pharmaceuticals Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
3/24/2023
Impel Pharmaceuticals Inc. today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update.
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SQI DIAGNOSTICS ANNOUNCES PROPOSED INSIDER SALES AND WARRANT EXERCISES TO FUND COMPANY
3/24/2023
SQI Diagnostics Inc. announces that certain insiders of the Company, who are also control persons of the Company and collectively own, or exercise control or direction over, an aggregate of 75% of the issued and outstanding common shares.
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Getinge recieves FDA premarket approval for the iCast™ covered stent system in the US
3/24/2023
Getinge's iCast™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.
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Pharming announces US FDA approval of Joenja® (leniolisib) as the first and only treatment indicated for APDS
3/24/2023
Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that the US Food and Drug Administration (FDA) has approved Joenja® (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.
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Orion Health strengthens North American operations with new technology and leadership
3/24/2023
Orion Health, a global leader in population health software, is strengthening its position in North America with new technology and the appointment of James Rice as Executive Vice President for North America.
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INVO Bioscience Announces Pricing of $3.0 Million Registered Direct Offering Priced At-The-Market
3/24/2023
INVO Bioscience, Inc. today announced that it has entered into a securities purchase agreement with a single healthcare focused institutional investor to purchase 3,680,000 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules.
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Enrollment Begins in FORESEE Clinical Trial Using Biocept’s CNSide™ to Evaluate Patients with Leptomeningeal Metastases
3/24/2023
Biocept, Inc. announces enrollment of the first patient in the FORESEE clinical trial with the Company’s proprietary cerebrospinal fluid assay CNSide (NCT05414123).
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Midatech Pharma PLC Announces Results of General Meeting
3/24/2023
Midatech Pharma PLC is pleased to announce that at the general meeting of the Company held earlier today all resolutions put to the Company's shareholders were duly passed.
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Vaccitech Reports Full-Year 2022 Financial Results and an Update on Corporate Developments
3/24/2023
Vaccitech plc today announced its financial results for year end 2022 and an overview of the Company’s progress.
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Stuart Peltz, Ph.D., Rare Disease Pioneer, to Retire as Chief Executive Officer of PTC Therapeutics
3/24/2023
PTC Therapeutics, Inc. (NASDAQ: PTCT ). Stuart Peltz , Ph.D., founding Chief Executive Officer (CEO) of PTC Therapeutics announced today that he is stepping down after 25 years.