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Innate Pharma Announces U.S. FDA Lifts Partial Clinical Hold on Lacutamab Clinical Program
1/4/2024
Innate Pharma SA announced that the U.S. Food and Drug Administration has lifted the partial clinical hold placed on the lacutamab IND.
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Kuros Biosciences Announces Three Advancements Related to its MagnetOsTM Portfolio Including Impressive Fusion Data from MAXA Prospective Randomized Clinical Trial and Two 510(k) Clearances from FDA
1/4/2024
Kuros Biosciences announced three advancements related to its MagnetOs portfolio of products: specifically positive results from the MAXA level 1 clinical trial comparing standalone MagnetOs to autograft in a real world patient population in the challenging posterolateral fusion procedure, and two 510 clearances from the U.S. Food and Drug Administration related to its MagnetOs family of products.
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It wasn't a merry end to 2023 for Amgen or Zealand Pharma, which received Complete Response Letters for Lumakras and for dasiglucagon in congenital hyperinsulinism.
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LumiThera Provides Update on FDA Review of Valeda Treatment for Dry AMD Patients
1/3/2024
LumiThera Inc. announced an update on the regulatory status of the Valeda® Light Delivery System.
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Invivyd Submits Request for Emergency Use Authorization (EUA) to U.S. FDA for VYD222 for the Pre-exposure Prevention of COVID-19 in Immunocompromised Adults and Adolescents
1/3/2024
Invivyd, Inc. announced that it has requested Emergency Use Authorization from the U.S. Food and Drug Administration for VYD222, a broadly neutralizing, half-life extended monoclonal antibody candidate, for the pre-exposure prevention of COVID-19 in immunocompromised adults and adolescents.
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OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of OBI-992
1/3/2024
OBI Pharma, a clinical stage oncology company, announced that the U.S. Food and Drug Administration has cleared an investigational new drug application for OBI-992, to conduct a Phase 1/2 study of its novel antibody - drug conjugate cancer therapy targeting TROP2.
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IRLAB is Granted an End-of-Phase 2 Meeting with the FDA for the Phase III-Ready Mesdopetam Program
1/3/2024
IRLAB Therapeutics AB announced that the US FDA has granted IRLAB an end-of-Phase 2 meeting for the mesdopetam program on February 20, 2024.
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Octapharma Announces Availability of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures
1/3/2024
Octapharma USA has announced Balfaxar® is now available. The new non-activated four factor prothrombin complex concentrate, approved by the U.S. FDA this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients with need for urgent surgery or invasive procedures.
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AnX Robotica Announces FDA Clearance for ProScan™: A Groundbreaking AI Assisted Reading Tool for Small Bowel Video Capsule Endoscopy
1/3/2024
AnX Robotica, a pioneering force in advanced gastrointestinal visualization technologies, is excited to announce the FDA clearance of NaviCam ProScan™.
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5 FDA Decisions to Watch in Q1
1/2/2024
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA's docket this quarter. -
FDA Roundup: January 2, 2024
1/2/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Atom Bioscience Receives FDA IND Clearance for Clinical Trial of ABP-745 for Acute Gout
1/2/2024
Atom Bioscience announced the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a Phase 1 clinical trial of ABP-745, an anti-inflammatory oral small molecule drug, for the treatment of acute gout.
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Diakonos Oncology Completes Phase 1 Glioblastoma Trial Recruitment; Receives FDA Orphan Drug Designation
1/2/2024
Diakonos Oncology Corporation, a clinical stage immuno-oncology company, announced it has completed enrollment for its Phase 1 trial of DOC1021, a unique dendritic cell vaccine, for Glioblastoma Multiforme.
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Intellipharmaceutics International Inc. Receives Conditional Approval to List on the TSX Venture Exchange
1/2/2024
Intellipharmaceutics International Inc. announces that, it has applied and received conditional approval to list the Company's common shares for trading on the TSX Venture Exchange as a Tier 2 Life Science Issuer.
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Microbot Medical Announced Positive Results of Its GLP Pivotal Pre-Clinical Study Where All Study Objectives Were Met
12/28/2023
Microbot Medical Inc. announces the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model.
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HANSIZHUANG Sets Sail in Indonesia Market
12/28/2023
Shanghai Henlius Biotech, Inc. announces that recently, PT Kalbio Global Medika, the subsidiary of Henlius' partner PT Kalbe Genexine Biologics, has received the relevant registration certificates issued by Indonesia's National Agency for Drug and Food Control for the approval of Henlius' self-developed and manufactured anti-PD-1 mAb HANSIZHUANG in Indonesia under the trade name Zerpidio® for the treatment of extensive stage small cell lung cancer.
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NeuroBo Pharmaceuticals Submits IND Application to the FDA for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity
12/28/2023
NeuroBo Pharmaceuticals, Inc. announced that it has submitted an Investigational New Drug application to the U.S. Food and Drug Administration.
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Sequana Medical submits Premarket Approval application to US FDA for alfapump® in recurrent or refractory ascites due to liver cirrhosis
12/28/2023
Sequana Medical NV announces that it has submitted a Premarket Approval application to the US Food and Drug Administration for alfapump, the Company’s fully implantable, wirelessly charged device for patients with recurrent or refractory ascites due to liver cirrhosis.
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Everest Medicines Announces New Drug Application Acceptance of Nefecon® in Taiwan for the Treatment of Primary IgA Nephropathy in Adult Patients
12/27/2023
Everest Medicines announced that its New Drug Application for Nefecon® has been accepted for review by the Taiwan Food and Drug Administration for the treatment of primary immunoglobulin A nephropathy in adult patients.
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Hoth Therapeutics Announces Expansion of FDA Cleared First-In-Human Clinical Trial For Cancer Patients of HT-001 at University of Miami
12/27/2023
Hoth Therapeutics, Inc., a patient-focused biopharmaceutical company, announced that it has received approval from the University of Miami to enroll patients for its first in human clinical trial of HT-001.