Abeona Therapeutics® Reports Third Quarter 2024 Financial Results and Recent Corporate Updates
FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of April 29, 2025 Company makes significant progress toward potential commercialization of pz-cel in 2025;
Theriva™ Biologics Reports Third Quarter 2024 Operational Highlights and Financial Results
Target patient enrollment of 92 evaluable patients achieved in the VIRAGE Phase 2b clinical trial of VCN-01 in patients with metastatic
Vaxart Provides Business Update and Reports Third Quarter 2024 Financial Results
Solid financial position enables Vaxart to attain multiple regulatory and clinical milestones Conference call today at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Vaxart,
Acumen Pharmaceuticals Reports Third Quarter 2024 Financial Results and Business Highlights
AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer’s disease, to complete enrollment in the first half of 2025Expect to announce topline results
Capricor Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update
Announced intent to file a biologics license application (BLA) for deramiocel to treat all patients with DMD-cardiomyopathy Rolling BLA
Viracta Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today reported financial results for the third quarter of 2024 and provided a business update.
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AstraZeneca: New drug data, promising earnings and a $3.5B R&D investment
AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...
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AstraZeneca, Daiichi Sankyo Submit New BLA for Datopotamab in Lung Cancer
AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) for accelerated approval for ...
AstraZeneca lifts 2024 outlook after Q3 beat, doubles down on US investments
Drugmaker AstraZeneca lifted its annual sales and profit forecast for the second time this year on Tuesday, helped by strong ...
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Omeros Corporation (OMER) Q3 2024 Earnings Call Transcript
As described in previous updates, we have been working closely with FDA regarding the anticipated resubmission of our Biologics License Application, or BLA for narsoplimab in hematopoietic stem ...
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LakeShore Biopharma Initiates Biologics License Application of PIKA Rabies Vaccine to the Drug Regulatory Authority of Pakistan
today announced the initiation of its Biologics License Application (BLA) submission to the Drug Regulatory Authority of Pakistan (DRAP) for the conditional approval of its PIKA rabies vaccine ...
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FDA Extends Review of CNTF Ocular Implant for Macular Telangiectasia
NT-501 is an investigational ocular implant that utilizes an encapsulated cell-based delivery system to deliver continuous ciliary neurotrophic factor.
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LakeShore commences BLA submission to DRAP for rabies vaccine
LakeShore Biopharma has commenced the submission of its biologics license application (BLA) to the Drug Regulatory Authority ...
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Abeona Therapeutics® Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa
CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona’s resubmission of ...
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Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa Under Review
The Food and Drug Administration (FDA) has accepted for review the resubmitted Biologics License Application (BLA) for prademagene zamikeracel for the treatment of recessive dystrophic epidermolysis ...