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AstraZeneca reported Monday that adding Lynparza to Imfinzi improved outcomes in mismatch repair proficient endometrial cancer, more than doubling the median duration of response in patients.
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New late-stage trial results for GSK’s Jemperli show improved overall and progression-free survival in a broader range of endometrial cancer patients, which could lead to a potential label expansion.
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Contineum Therapeutics joined the 2024 initial public offering class on Friday with an SEC filing. The biotech will use the IPO proceeds to complete a Phase II trial for its most mature candidate targeting multiple sclerosis.
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Following GSK’s lead, Pfizer plans to lower its interest in Haleon from 32% to approximately 24%, with the sale of 630 million ordinary shares in the consumer healthcare spinoff.
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With Boehringer Ingelheim’s announcement earlier this month that it was capping U.S. inhaler costs at $35 per month, AstraZeneca on Monday followed suit.
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The FDA will close out a hectic month of March with a flurry of target action dates, including ones for lymphoma and CKD anemia treatments.
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With its FDA approval last week and first-to-market advantage, Madrigal Pharmaceuticals’ Rezdiffra will set the standard for other metabolic dysfunction-associated steatohepatitis candidates in development.
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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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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
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Knowing that you want to integrate AI is one thing—but how do you actually do it? For biotech companies kickstarting their generative AI journey, here are four things to consider.
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Positive results from Phase II clinical trial (CGZ203 study) of Chiglitazar monotherapy for non-alcoholic steatohepatitis
3/18/2024
On March 18 2024, Shenzhen chipscreen biosciences Co., Ltd. (hereinafter referred to as "chipscreen biosciences", stock code: 688321. SH) announced that the Phase II clinical trial (CGZ203 study) of chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) was successfully completed with data cleaning and database locking on February 22, 2024.
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New Research Shows the PrecivityAD2™ Blood Test Has High Accuracy Compared to Amyloid PET Scans in Individuals with Cognitive Impairment
3/18/2024
New research finds that C₂N Diagnostics, LLC’s proprietary algorithm used in its PrecivityAD2 blood test, which is used by healthcare providers to determine Alzheimer’s disease (AD) pathology in individuals with early cognitive impairment, can identify brain amyloid status with “sensitivity, specificity, positive and negative predictive values that approximate those of amyloid positron emission tomography (PET) imaging.”
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FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
3/18/2024
Today, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD).
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Nexus Pharmaceuticals Launches Baclofen Injection, USP
3/18/2024
Today, Nexus Pharmaceuticals announced the launch of Baclofen Injection, USP.
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Inventiva announces positive results from the Phase II, LEGEND, Proof-of-Concept study combining lanifibranor with empagliflozin in patients with MASH/NASH and T2D
3/18/2024
Inventiva (Euronext Paris and Nasdaq: IVA) today announces positive results of its interim analysis of the Phase II, Proof-of-Concept clinical trial, LEGEND, evaluating lanifibranor in combination with empagliflozin in patients with MASH/NASH and poorly controlled Type 2 Diabetes (T2D).
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PMV Pharmaceuticals PYNNACLE Phase I Data of Rezatapopt in Advanced Ovarian Cancer Featured in Late-Breaking Oral Presentation at 2024 SGO Annual Meeting on Women’s Cancer
3/18/2024
PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced that a Phase 1 analysis reported promising anti-tumor activity of rezatapopt (PC14586) in heavily pre-treated patients with advanced ovarian cancer harboring a TP53 Y220C mutation.
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QDOSE® Platform Partnership for Personalized Dosimetry in Radiopharmaceutical Therapy
3/18/2024
Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has entered into an agreement to commercially partner the QDOSE® dosimetry software platform with ABX-CRO Advanced Pharmaceutical Services Forschungsgesellschaft mbH (ABX-CRO), a full-service contract research organization (CRO) based in Dresden, and its development partner, Stockholm-based Quantinm AB.
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New Consortium Launches Colorado Hub for Health Impact, a National Economic Development Campaign to Attract Health Innovation Companies to the Stat
3/18/2024
20+ Life Sciences Organizations, Economic Development Groups, Local Governments, Developers, and Builders Invest to Bring New, High-Growth Companies to Colorado
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Anavex Life Sciences Initiates Placebo-Controlled U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia
3/18/2024
Anavex Life Sciences Corp today announced that the first patient in its U.S. FDA cleared placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia has been screened ahead of schedule.
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Abeona Therapeutics Reports Full Year 2023 Financial Results and Announces Completion of FDA Inspections
3/18/2024
Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the full year of 2023 and provided an update on progress toward achieving key corporate objectives.