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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Bio-Path Holdings, Inc. Announces Closing of $1.2 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
4/19/2024
Bio-Path Holdings, Inc. announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules of an aggregate of 375,000 shares of its common stock at a purchase price of $3.225 per share and concurrent private placement of unregistered warrants to purchase up to an aggregate of 375,000 shares of common stock.
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Hepion Pharmaceuticals Initiates Wind-Down Activities in Phase 2b ‘ASCEND-NASH’ Trial
4/19/2024
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) today announced that it has begun wind-down activities in its ASCEND-NASH Trial, while continuing to explore strategic alternatives, as previously announced in December 2023.
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Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4) - April 19, 2024
4/19/2024
Iovance Biotherapeutics, Inc. announced that on April 18, 2024, the Company approved the grant of inducement stock options covering an aggregate of 79,310 shares of Iovance’s common stock to thirty-seven new, non-executive employees.
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Vaccinologists Keith Klugman and Shabir Madhi Awarded Sabin’s Prestigious Gold Medal; Infectious Diseases Epidemiologist Nicole Basta Receives Rising Star Award
4/19/2024
The Sabin Vaccine Institute yesterday presented the Albert B. Sabin Gold Medal to physician-researchers Keith Paul Klugman and Shabir Ahmed Madhi, and its Rising Star award to infectious diseases epidemiologist Nicole Elaine Basta at a ceremony in the National Academy of Sciences building in Washington D.C.
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Tiziana Life Sciences Announces Study Results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA Highlighted in Neurology Today®
4/19/2024
Tiziana Life Sciences, Ltd. today announced that a study related to its lead candidate, foralumab, was highlighted in Neurology Today®, the official news source of the American Academy of Neurology (AAN), in an article titled, “Anti-CD3 Antibody Foralumab Shows Promise in PIRA, Measured by Novel PET Ligand.”
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Two Clinical Trials Identify a Better Way to Target Appropriate Antibiotics for Patients Hospitalized With Pneumonia or Urinary Tract Infection
4/19/2024
Two large multi-state studies uncovered a highly effective way to improve antibiotic selection for patients hospitalized with pneumonia or urinary tract infections (UTI), enabling better antibiotic stewardship in hospitals, according to research studies published today in the Journal of the American Medical Association (JAMA).
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Panbela Announces Poster Presentation at American Association for Cancer Research:Ivospemin/doxorubicin combination modulates polyamine metabolism to improve survival in murine ovarian cancer models
4/18/2024
Panbela Therapeutics, Inc., a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer announces a poster presentation highlighting the results for ivospemin as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research, which took place April 10, 2024.
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TriLink BioTechnologies® Announces New San Diego Facility for Late Phase mRNA Drug Substance Production
4/18/2024
TriLink BioTechnologies, a Maravai LifeSciences company and global provider of life science reagents and services, has announced the grand opening of its new cGMP mRNA manufacturing facility.
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Vir Biotechnology Announces Nomination of Norbert Bischofberger, Ph.D. and Ramy Farid, Ph.D. to its Board of Directors
4/18/2024
Vir Biotechnology, Inc. announced the nomination of Norbert Bischofberger, Ph.D. and Ramy Farid, Ph.D. to its Board of Directors at its upcoming annual meeting of stockholders on May 29, 2024.
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Red Biotechnology Market Size, CAGR, Trends, Report 2024 to 2033
4/18/2024
According to Vision Research Reports, the global red biotechnology market size was estimated at around USD 492.74 billion in 2023
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IMUNON’s IND Application Cleared to Begin Human Testing of IMNN-101
4/18/2024
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces receipt of clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial with a seasonal COVID-19 booster vaccine.
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Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) Showed Positive Results in Patients With Giant Cell Arteritis
4/18/2024
AbbVie (NYSE: ABBV) today announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib (RINVOQ®; 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis (GCA).
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Texas Biomed researching vaccines and treatments for highly pathogenic avian influenza
4/18/2024
Researchers at Texas Biomedical Research Institute (Texas Biomed) are studying potential vaccines, antivirals and antibodies against highly pathogenic avian influenza, including H5N1 strains that closely mirror the one recently detected in cows, chickens and one person in Texas.
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Soligenix Announces Pricing of $4.75 Million Public Offering
4/18/2024
Soligenix, Inc. announced the pricing of its public offering of 11,875,000 shares of common stock and warrants to purchase up to 11,875,000 shares of common stock at a combined public offering price of $0.40 per share and accompanying warrant for aggregate gross proceeds of approximately $4.75 million, before deducting placement agent fees and other offering expenses.
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Bio-Path Holdings, Inc. Announces $1.2 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
4/18/2024
Bio-Path Holdings, Inc. announced that it has entered into a definitive agreement with certain institutional investors for the issuance and sale of 375,000 shares of its common stock at a purchase price per share of $3.225 in a registered direct offering priced at-the-market under Nasdaq rules.
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Intuitive Announces First Quarter Earnings 2024
4/18/2024
Intuitive, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced financial results for the quarter ended March 31, 2024.
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TG Therapeutics Announces Additional Data Presentations for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting
4/18/2024
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced two additional data presentations from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI ® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 American Academy of Neurology (AAN) annual meeting, being held in Denver, Colorado.
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Benitec Biopharma Reports Positive Interim Clinical Trial Data for First OPMD Subject Treated with BB-301 in Phase 1b/2a Study
4/18/2024
Benitec Biopharma Inc. today announces positive interim clinical data from the 90-day timepoint following the administration of BB-301 to the study’s first subject (Subject 1) treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD).
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TaiGen Successfully Completes TG-1000 Phase III Study
4/18/2024
TaiGen Biotechnology Company, Limited announces that the business partner, Joincare Pharmaceutical, has completed the unblinding of influenza antiviral TG-1000 phase III study.