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Sarepta Therapeutics and its partner, Roche, presented promising functional data from several trials of its gene therapy for Duchenne muscular dystrophy.
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Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.
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Eisai and Biogen's BLA for lecanemab for Alzheimer's disease received FDA Priority Review with a target action date of January 6, 2023, while Roche's lymphoma drug scored the same designation.
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A cancer drug co-developed by Coherus BioSciences and Junshi Biosciences, toripalimab, is getting another opportunity before the U.S. Food and Drug Administration.
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NextCure Announces Development of a Highly Specific Immunohistochemical Diagnostic for Siglec-15-positive Tumors as reported in Laboratory Investigation
7/6/2022
NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the publication of a paper titled “Development of an Immunohistochemical Assay for Siglec-15” in Laboratory Investigation.
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Inspire Medical Systems, Inc. Announces FDA Approval of Expanded, Full-Body MRI Compatibility with Inspire Therapy
7/6/2022
Inspire Medical Systems, Inc. today announced that the United States Food and Drug Administration (FDA) has approved additional magnetic resonance imaging (MRI) scan conditions for use with Inspire therapy.
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Cend Therapeutics Announces Publication of Pancreatic Cancer Trial Data in the Lancet Gastroenterology and Hepatology
7/6/2022
Cend Therapeutics, Inc. today announced that The Lancet Gastroenterology and Hepatology published data from the Phase 1b study of CEND-1.
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Immutep Granted Japanese Patent for IMP761, A First-In-Class Immunosuppressive Antibody Targeting Lag-3
7/6/2022
Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is pleased to announce the grant of a new patent (number 7074341) entitled “Anti-LAG-3 Antibodies” by the Japanese Patent Office.
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Eyenovia Strategic Partner Arctic Vision Enrolls First Patient in Phase III Clinical Trial of ARVN003 (MicroLine) for Presbyopia in China
7/6/2022
Eyenovia, Inc. today announced that its strategic partner, Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, enrolled the first patient in its Phase 3 clinical trial of ARVN003 (MicroLine) for presbyopia.
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Ring Therapeutics Publishes the First Human Anellovirus Structure with Key Insights on Its Assembly, Function and Immune Evasion Properties
7/6/2022
Ring Therapeutics, a life sciences company founded by Flagship Pioneering to revolutionize programmable medicines with its commensal virome platform, today announced a pre-print publication in bioRxiv featuring the first anellovirus structure identified from a synthetically produced human anellovirus capsid protein.
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Evoke Pharma Expands IP Portfolio with Addition of Canadian Patent Covering GIMOTI Method of Use
7/6/2022
Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced that the Canadian Intellectual Property Office granted the Company a key patent for its previously submitted application (CA 2984736) “Nasal Formulations of Metoclopramide.”
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Applied Molecular Transport Announces Top-line Phase 2 Results from MARKET Combination Trial of Oral AMT-101 in Patients with Moderate-to-Severe Ulcerative Colitis
7/6/2022
Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT) today announced top-line Phase 2 results from the MARKET combination trial for AMT-101 in biologic-naïve patients with moderate-to-severe UC.
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Coherus and Junshi Biosciences Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
7/6/2022
Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) and Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab.
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Junshi Biosciences and Coherus Announce FDA Acceptance of Resubmission of BLA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
7/6/2022
Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) announced today that the United States Food and Drug Administration ("FDA") has accepted for review the Biologics License Application (“BLA”) resubmission for toripalimab.
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Sarepta Therapeutics’ Investigational Gene Therapy SRP-9001 for Duchenne Muscular Dystrophy Demonstrates Significant Functional Improvements Across Multiple Studies
7/6/2022
Sarepta and its partner Roche present new results and analyses at the International Congress on Neuromuscular Diseases (ICNMD), which demonstrate that SRP-9001 shows consistent, statistically significant functional benefits in individuals with Duchenne versus a propensity-weighted external control that continue to positively diverge from natural history disease course.
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Humanigen Announces Peer-Reviewed Publication in Thorax Supporting Early Treatment of Hospitalized COVID-19 Patients with Lenzilumab Guided by C-Reactive Protein
7/6/2022
Humanigen Announces Peer-Reviewed Publication in Thorax Supporting Early Treatment of Hospitalized COVID-19 Patients with Lenzilumab Guided by C-Reactive Protein.
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Immunome’s COVID-19 Cocktail Retains Neutralizing Activity Against the Most Prevalent Omicron Subvariants* in the US, BA.4/5 and BA.2.12.1
7/6/2022
Immunome, Inc. today announced that their cocktail (IMM-BCP-01) retained activity against the BA.4/5 and BA.2.12.1 subvariants in pseudovirus testing.
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Avinger Announces Filing of 510(k) Submission for Tigereye ST Image-Guided CTO Crossing System
7/6/2022
Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the company has submitted a 510(k) application to the U.S. Food & Drug Administration (FDA) for the Tigereye ST catheter.
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Zenith Epigenetics Announces Start of Several National Cancer Institute (NCI)-Sponsored Oncology Clinical Trials
7/6/2022
Zenith Epigenetics Ltd. (“Zenith” or the “Company”) announced today that its leading BET inhibitor, ZEN-3694, is being evaluated in seven NCI sponsored clinical trials for safety and efficacy in multiple oncology indications with significant unmet need, through the NCI’s Cancer Therapy Evaluation Program (CTEP).
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US FDA AWARDS RARE PEDIATRIC DISEASE DESIGNATION (RPDD) TO PAXALISIB FOR AT/RT, A RARE FORM OF CHILDHOOD BRAIN CANCER
7/6/2022
Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia's paxalisib for the treatment of atypical rhabdoid / teratoid tumors (AT/RT).