Seres Therapeutics Receives Feedback From FDA on SER-155 Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) Development Approach
FDA has provided input on key elements of the SER-155 allo-HSCT clinical development plans including support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) as ...
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FDA Accepts BLA Reubmission For Regeneron's Odronextamab In Follicular Lymphoma
In the previous submission, the FDA had issued a complete response letter ... of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan ...
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Opus Genetics Announces FDA Fast Track, Trial Enrollment Updates For Phentolamine 0.75%
(RTTNews) - Opus Genetics, Inc. (IRD) announced Wednesday that its Phentolamine Ophthalmic Solution 0.75 percent has been granted Fast Track designation by the U.S. FDA. This designation is for ...
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Telix Pharma : FDA Accepts BLA For TLX250-CDx For Kidney Cancer Imaging
The FDA granted a Priority Review and provided a ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
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Mirum Pharma's CTEXLI Gets FDA Approval For Treatment Of Adults With Cerebrotendinous Xanthomatosis
"The FDA's approval of CTEXLI is tremendous as it ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
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Regeneron Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Odronextamab in Relapsed/Refractory Follicular Lymphoma
Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in ...
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FDA Grants Priority Review To Precigen's PRGN-2012 For Recurrent Respiratory Papillomatosis
If approved, PRGN-2012 will be the first FDA-approved therapy for RRP ... Tuesday the stock is up by 16.57 percent at $2.04 on the Nasdaq. The views and opinions expressed herein are the views ...
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Pyxis Oncology Announces Fast Track Designation from FDA for PYX-201 in Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted ...
Pyxis Oncology rises on FDA fast track tag for lead asset
Pyxis Oncology (PYXS) stock rises as the FDA issues fast track designation for its lead asset PYX-201 in head and neck cancer ...
Viatris slides as FDA scrutiny on India plant clouds outlook
Viatris (VTRS) stock falls as company faces challenges with India plant affecting 2025 outlook and its Q4 2024 results miss ...
Why These 15 Biotech Stocks Are Skyrocketing So Far In 2025
No matter the market environment, you’ll always find entertainment in the biotech space. There will always be biotech stocks ...
10 Best Weight Loss Drug Stocks to Buy According to Analysts
In this article, we will be taking a look at the 10 best weight loss drugs to buy according to analysts.