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The SEC said that Yum China, BeiGene, Zai Lab, HutchMed and ACM Research are all at risk if they do not give U.S. regulators access to their audit records.
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Pfizer and Eli Lilly are forging ahead with ulcerative colitis (UC) research after posting positive results from their respective Phase III studies.
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Imugene and City of Hope announced that the first patient has begun treatment in a Phase I clinical trial, investigating the safety and efficacy of CF33-hNIS in adults with metastatic or advanced tumors.
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Genocea's board of directors voted to wind down ongoing operations and terminate its remaining staff, except for those necessary to see the company's closing.
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Caladrius Biosciences announced it was suspending enrollment in its Phase IIb FREEDOM study assessing xowna for coronary microvascular dysfunction (CMD) due to supply chain issues.
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The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.
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Alnylam Pharmaceuticals announced Tuesday new positive results from the Phase III ILLUMINATE-C trial of lumasiran for advanced primary hyperoxaluria type 1 (PH1).
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If approved, etranacogene dezaparvovec would be the first gene therapy treatment for hemophilia B.
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Two months after closing its Series A financing round, KaliVir Immunotherapeutics forged an exclusive licensing and collaboration agreement with Roche.
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A new report in La Merie Publishing describes and analyzes cadherin 17 as a promising target for drug development, which has largely gone unexploited.
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In the age of COVID-19, moving to a remote workforce is a necessary but often challenging task. To help, we've compiled some tips that can help you while managing a remote workforce.
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FDA Grants Breakthrough Device Designation to Anumana’s ECG Pulmonary Hypertension Early Detection AI Algorithm
5/24/2022
FDA Grants Breakthrough Device Designation to Anumana’s ECG Pulmonary Hypertension Early Detection AI Algorithm.
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ENB Therapeutics Announces Orphan Drug Designation Granted by FDA for ENB-003 for the Treatment of Pancreatic Cancer
5/24/2022
ENB Therapeutics, Inc., a clinical stage biotechnology company pioneering a new and differentiated class of therapeutics targeting the endothelin B receptor (ETBR) inhibitor, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its lead product candidate, ENB-003.
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Synlogic Receives Positive Opinion on Orphan Designation from the European Medicines Agency for SYNB1618 for the Treatment of Phenylketonuria
5/24/2022
Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, today announced that the European Medicines Agency (EMA) issued a positive opinion on the Company’s application for orphan designation for SYNB1618 for the treatment of phenylketonuria (PKU).
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Odyssey Therapeutics Appoints Darryl Patrick, D.V.M., Ph.D., as Executive Vice President of Non-Clinical Development
5/24/2022
Odyssey Therapeutics, Inc. , a biotechnology company pioneering next generation precision immunomodulators and oncology medicines, today announced the appointment of Darryl Patrick , D.V.M., Ph.D., as Executive Vice President of Non-Clinical Development.
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CASI PHARMACEUTICALS ENTERES INTO SUBLICENSE AGREEMENT WITH TIANSHI PHARMACEUTICALS FOR ANTI-CD38 MONOCLONAL ANTIBODY (MAB) CID-103 IN AUTOIMMUNE FIELD
5/24/2022
CASI Pharmaceuticals, Inc. today announced the signing of a Sublicense Agreement with Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd., ("TIANSHI") a clinical stage pharmaceutical company organized and existing under the laws of the People's Republic of China ("PRC").
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bioMerieux receives Health Canada Approval for BIOFIRE Blood Culture Identification 2 (BCID2) Panel for Rapid Molecular Bloodstream Infection Identification
5/24/2022
bioMérieux a world leader in the field of in vitro diagnostics, announces that its BIOFIRE® Blood Culture Identification 2 (BCID2) Panel has received Health Canada approval.
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Tesis Biosciences to Provide Genetic Testing Services for Florida ACO Pathways Health Partners
5/24/2022
Tesis Biosciences , the leader in targeted genetic sequencing, has been selected by Pathways Health Partners (PHP), an accountable care organization (ACO) dedicated to solving the challenges facing healthcare today, to provide member practices with next-generation sequencing (NGS) testing and precision medicine services.
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Precipio Receives CE-IVD Certification to Market Multiple HemeScreen® Panels in EuropeThis Regulatory Approval Opens the Company’s Reach to the European Market
5/24/2022
Specialty cancer diagnostics company, Precipio, Inc. (NASDAQ: PRPO), today announced that it has received CE-IVD approval for sale of its HemeScreen® reagents in the European Union.
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inHEART RECEIVES FDA CLEARANCE FOR NOVEL 3D CARDIAC MODELING SOLUTION
5/24/2022
inHEART, a privately-held medical device company delivering the world's most sophisticated digital twin of the heart, announced today that it has received FDA 510(k) clearance for its inHEART MODELS software suite that enables 3D visualization and analysis of anatomical structures for pre-procedural planning and intraprocedural use.