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StageZero Life Sciences Announces Delay to Fourth Quarter and Year End 2023 Financial Results
4/2/2024
StageZero Life Sciences, Ltd. announced a delay in the filing of its audited consolidated financial statements for the year ended December 31, 2023, management's discussion and analysis for the same period and management certifications of annual filings beyond the deadline of April 2, 2024 prescribed by Canadian securities laws.
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FDA Roundup: April 2, 2024
4/2/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Protembis Announces First Patient Enrolled in the PROTEMBO IDE Pivotal Trial
4/2/2024
Protembis GmbH, a privately-held emerging cardiovascular medical device company, announced the enrollment of the first patient in the PROTEMBO Investigational Device Exemption Pivotal Trial.
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Rocket Pharmaceuticals Announces European Medicines Agency Acceptance of RP-L102 Marketing Authorization Application for the Treatment of Fanconi Anemia
4/2/2024
Rocket Pharmaceuticals, Inc. announced that the European Medicines Agency accepted the Marketing Authorization Application for RP-L102, its lentiviral vector-based investigational gene therapy for Fanconi Anemia, complementation group A, a rare genetic disorder caused by mutations in the FANCA gene affecting DNA repair and characterized by bone marrow failure, cancer predisposition, and congenital malformations.
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The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
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With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science.
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Fresh from its IPO, Fractyl Health got an Investigational Device Exemption from the FDA, clearing a pivotal study of its Revita system to help maintain weight loss following the discontinuation of GLP-1 drugs.
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April kicks off with three FDA target action dates, including one that could potentially set the stage to move CAR-T therapies into earlier lines of treatment.
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Submission of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's disease to the U.S. FDA completed
4/1/2024
BioArctic AB's partner Eisai announced that Eisai has submitted a supplemental Biologics License Application for monthly lecanemab-irmb intravenous maintenance dosing to the U.S. Food and Drug Administration.
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Antibe Announces FDA Clinical Hold on Otenaproxesul and Legal Action by Nuance
4/1/2024
Antibe Therapeutics Inc. announced that it received verbal notice on the afternoon of March 28, 2024 from the U.S. Food and Drug Administration that otenaproxesul has been placed on clinical hold, postponing the initiation of the planned Phase II trial.
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Eisai Completes Submission of LEQEMBI® (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA
4/1/2024
Eisai Co., Ltd. and Biogen Inc. announced that Eisai submitted to the U.S. Food and Drug Administration a Supplemental Biologics License Application for monthly lecanemab-irmb intravenous maintenance dosing.
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Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs
4/1/2024
Fractyl Health, Inc. announced U.S. Food and Drug Administration approval of a pivotal Investigational Device Exemption to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist drug therapy, addressing a key unmet need in the treatment of obesity.
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Gilead Sciences’ Vemlidy on Thursday secured a label expansion from the FDA, allowing the antiviral drug’s use to treat chronic hepatitis B in pediatric patients aged six years and older.
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Citing the need for more time to review a major amendment, the FDA is pushing the target action date for the investigational aldose reductase inhibitor in the treatment of classic galactosemia to Nov. 28, 2024.
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FDA Roundup: March 29, 2024
3/29/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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IASO Bio Announces NMPA's IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma
3/29/2024
IASO Bio announced that China National Medical Products Administration has approved the Investigational New Drug application for Equecabtagene Autoleucel, a self-developed fully-human anti-B cell maturation antigen chimeric antigen receptor autologous T-cell injection, for an expanded indication in treating relapsed and/or refractory multiple myeloma patients who have undergone 1-2 lines of prior therapies and are refractory to lenalidomide.
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Keytruda can now be used in the European Union for patients with resectable non-small cell lung cancer at high risk of recurrence in combination with platinum chemotherapy, then continued as a monotherapy afterwards.
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After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
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4DMT Announces Update on Regulatory Interactions and Development Path for 4D-710 for Treatment of Cystic Fibrosis
3/28/2024
4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced an update on its regulatory interactions and development path for 4D-710, an aerosolized genetic medicine for the treatment of CF lung disease.
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Ceapro Receives Final Court Approval for Merger with Aeterna Zentaris
3/28/2024
Aeterna Zentaris Inc. and Ceapro Inc. are pleased to announce that the Court of King's Bench of Alberta has issued a final order approving the arrangement described in the previously announced definitive agreement to combine the operations of Ceapro and Aeterna in an all-stock merger of equals transaction.