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The company paid $85 million upfront to Quell Therapeutics to develop Treg therapies for Type 1 diabetes and inflammatory bowel disorder, with the deal potentially worth more than $2 billion.
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In a 6-0 vote, the FDA’s advisory committee Friday affirmed that trial data confirmed the clinical benefit of Eisai and Biogen’s Leqembi (lecanemab) for the treatment of Alzheimer’s disease.
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Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.
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The FDA’s Antimicrobial Drugs Advisory Committee voted 21–0 that the companies’ respiratory syncytial virus antibody, nirsevimab, has a favorable benefit-risk profile in infants and young children.
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The Centers for Medicare & Medicaid Services announced Friday it will impose inflation penalties on 43 Medicare Part B drugs in the third quarter of 2023. The action follows fines on 27 drugs in March.
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Humanigen Presents Promising New Hematologic Data from PREACH-M Trial for Chronic Myelomonocytic Leukemia Treatment at the 2023 European Hematology Association Congress
6/9/2023
Humanigen, Inc. (Nasdaq: HGEN) today extended previously reported results by presenting additional, statistically significant hematologic improvements and reductions in inflammatory markers from lenzilumab, its investigational drug
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Stem Cell Therapy Market Size to Reach Around USD 31.41 BN by 2030
6/9/2023
The global stem cell therapy market size was estimated at USD 11.22 billion in 2022 and it is projected to reach around USD 31.41 billion by 2030 and growing at a compound annual growth rate (CAGR) of 13.73% during the forecast period 2023 to 2030.
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ACROBiosystems Aneuro Partners with Diagnostic Biochips to Accelerate Neuroscience Drug Discovery
6/9/2023
ACROBiosystems, through ACRO Certify and under its Aneuro brand, recently announced the launch of in vivo electrophysiology solutions for neuroscience research with Diagnostic Biochips.
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Sumitomo Pharma Oncology, Inc. Presents Updated Preliminary Data from Phase 1/2 Clinical Study Evaluating Investigational Agent TP-3654 in Patients with Myelofibrosis at European Hematology Association 2023 Hybrid Congress
6/9/2023
Sumitomo Pharma Oncology, Inc., today presented updated preliminary data from the ongoing Phase 1/2 study evaluating TP-3654, an investigational selective oral PIM1 kinase inhibitor, in patients with myelofibrosis (MF) previously treated with or ineligible for JAK inhibitor therapy.
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Inspire Medical Systems, Inc. Announces FDA Approval for Apnea Hypopnea Index Indication Expansion and Increased Body Mass Index Labeling
6/9/2023
Inspire Medical Systems, Inc. announced today that it has received approval from the Food and Drug Administration (FDA) on an expanded indication.
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Milla Pharmaceuticals Inc. and the Alter Pharma Group Announce Yet Another “First Cycle” FDA Approval for an Abbreviated New Drug Application (ANDA), Dexmedetomidine Hydrochloride Injection
6/9/2023
Milla Pharmaceuticals Inc., a subsidiary of the Alter Pharma Group, announced that it has received FDA approval for its generic version of Precedex®, Dexmedetomidine Hydrochloride Injection 4mcg/ml in 50mL and 100mL, and plans to launch in the very near future.
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Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety and Pharmacodynamic Data for DARE-VVA1
6/9/2023
Daré Bioscience, Inc. today announced the publication of results of its Phase 1/2 clinical study of DARE-VVA1, a proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvovaginal atrophy (VVA) in women without the use of hormones.
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NRx Pharmaceuticals Announces Closing of $6.28 Million Registered Direct Offering
6/9/2023
NRx Pharmaceuticals, Inc. today announced that it has closed its previously announced registered direct offering for the purchase and sale of 9,670,002 shares of common stock at a purchase price of $0.65 per share of common stock.
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Kymera Therapeutics Announces Updated Clinical Data from the Phase 1 Trials of STAT3 Degrader KT-333 and IRAKIMiD Degrader KT-413
6/9/2023
Kymera Therapeutics, Inc. (NASDAQ: KYMR) today announced new data demonstrating that its oncology programs KT-333 and KT-413 continue to demonstrate substantial target knockdown in ongoing Phase 1a dose escalation clinical trials, with no dose limiting toxicities (DLTs) observed.
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Astellas Submits New Drug Application for Zolbetuximab in Japan
6/9/2023
Astellas Pharma Inc. announced the submission of a New Drug Application on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare for zolbetuximab, a first-in-class investigational Claudin 18.2 -targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
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Protagonist Therapeutics Plans a Follow-on Two-Year Extension Study to Enable Further Evaluation of the Long-Term Effects of Rusfertide
6/9/2023
Protagonist Therapeutics, Inc. announced today that Ronald Hoffman, MD, Icahn School of Medicine at Mount Sinai, provided a press briefing this morning on the late-breaking oral presentation abstract LB2710 : Targeted Therapy of Uncontrolled Erythrocytosis in Polycythemia Vera with the Hepcidin Mimetic, Rusfertide.
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TPG and AmerisourceBergen Announce Completion of Acquisition of OneOncology
6/9/2023
TPG and AmerisourceBergen Corporation (NYSE: ABC) today announced the completion of their previously announced acquisition of OneOncology, a network of leading oncology practices.
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Elevation Oncology Announces Pricing of $50 Million Public Offering
6/9/2023
Elevation Oncology, Inc. announced the pricing of an underwritten public offering of 17,810,000 shares of its common stock and, in lieu of common stock to investors that so choose, pre-funded warrants to purchase up to an aggregate of 4,440,000 shares of common stock and accompanying warrants to purchase one share of common stock for each share of common stock or pre-funded warrant sold.
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Shionogi Enrolls the First Participant in Japan in its Global Phase 3 Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection
6/9/2023
Shionogi & Co., Ltd. today announced the first participant has been enrolled in Japan in its global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP).
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China Approves the World's First Vaccine against XBB Descendent Lineages of SARS-CoV-2 for Emergency Use
6/9/2023
On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent Protein Vaccine developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities in China.