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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
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Biotech Beach
QuidelOrtho to Present at 42nd Annual J.P. Morgan Healthcare Conference
QuidelOrtho Corporation announced that Douglas Bryant, President and Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 8, 2024, in San Francisco, CA.
December 22, 2023
·
1 min read
Business
Catheter Precision, Inc. Reports Third Quarter Results of Operations and Filing of Third Quarter 10-Q
Catheter Precision, Inc. announced corporate highlights of the third quarter of 2023.
December 22, 2023
·
8 min read
Drug Development
Tyra Biosciences Doses First Patient with TYRA-200 and Provides Positive Updates on TYRA-300
Tyra Biosciences, Inc. today announced that it has initiated the SURF201 Phase 1 study of TYRA-200 and provided positive updates on its oral FGFR3-selective inhibitor, TYRA-300.
December 22, 2023
·
8 min read
Drug Development
First patient dosed in Clarity’s registrational Phase III prostate cancer trial with Cu-64 SAR-bisPSMA
Clarity Pharmaceuticals is pleased to announce that the first patient has been dosed in its pivotal Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, CLARIFY (NCT06056830)1, at the Urology Cancer Center / XCancer Omaha, NE.
December 22, 2023
·
6 min read
Drug Development
Amylyx Pharmaceuticals Announces First Participant Dosed in the Global Phase 3 ORION Study of AMX0035 in Progressive Supranuclear Palsy (PSP)
Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the first participant has been dosed in ORION, a randomized, double-blind, placebo-controlled Phase 3 clinical trial of AMX0035.
December 22, 2023
·
7 min read
Deals
Cyclacel Pharmaceuticals Announces Registered Direct and Private Placement Offering Priced At-The-Market Under Nasdaq Rules
Cyclacel Pharmaceuticals, Inc. announced today that it has entered into a definitive agreement for the purchase and sale of 388,200 shares of the Company’s common stock (or pre-funded warrants in lieu thereof) at a purchase price of $3.315 per share of common stock.
December 22, 2023
·
6 min read
RaySearch releases RayStation 2024A
RaySearch Laboratories AB announces the launch of RayStation®* 2024A, the latest version of the company’s comprehensive treatment planning system.
December 22, 2023
·
2 min read
Policy
Cellusion Receives U.S. FDA Orphan Drug Designation for CLS001
Cellusion Inc., a deep tech start-up developing a novel cell therapy, announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to our regenerative medicine product “iPS cell-derived corneal endothelial cell substitute” for the treatment of bullous keratopathy.
December 22, 2023
·
3 min read
Policy
Zealand Pharma submits New Drug Application to the US FDA for glepaglutide in short bowel syndrome
Zealand Pharma A/S announced the submission of a New Drug Application to the US Food and Drug Administration for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome dependent on parenteral support.
December 22, 2023
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6 min read
FDA
FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL)
BeiGene, Ltd. today announced the U.S. Food and Drug Administration (FDA) has approved a label update for BRUKINSA® (zanubrutinib) to include superior progression-free survival (PFS) results from the Phase 3 ALPINE trial comparing BRUKINSA against IMBRUVICA® (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
December 22, 2023
·
12 min read
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