Bioatla Inc. has received FDA clearance of its IND application for BA-3361, a conditionally active biologic (CAB)-Nectin-4 antibody-drug conjugate (ADC) for the treatment of multiple tumor types.
Eisbach Bio GmbH has announced FDA clearance of its IND application for EIS-12656, a first-in-class orally bioavailable and blood-brain barrier-penetrant allosteric inhibitor of ALC1 (CHD1L), a key molecular machine in DNA repair. Enrollment will open in the second quarter in a phase I/II trial in patients with genetically defined advanced solid tumors, including patients progressing under PARP inhibitor treatment.
Vyne Therapeutics Inc. has received IND clearance from the FDA allowing it to initiate a first-in-human phase Ia study of VYN-202, an oral small-molecule BD2-selective BET inhibitor for autoimmune diseases.
Checking off another item on its PDUFA VII to-do list, the U.S. FDA is releasing a draft guidance on using a logic model framework for risk evaluation and mitigation strategies (REMS).
Masimo Corp.’s pride and joy, the Stork baby monitor, achieved a new developmental milestone with U.S. FDA clearance for over-the-counter marketing. The agency cleared Stork, which monitors key vital signs including oxygen saturation level, pulse rate and skin temperature, for use on a prescription basis in December. It has been available in the U.S. as a health and wellness device since August 2023.
Cytovale Inc. has posted a feverish run of wins lately. The company gained U.S. FDA clearance for its Intellisep rapid test for sepsis in January 2023, raised $84 million in a series C in November and just published results showing the test has negative predictive value of 97.5%.
Apple Inc. said the U.S. FDA has approved the Apple Watch's atrial fibrillation (AF) history feature under its rigorous Medical Device Development Tools (MDDT) program that specifies what devices health professionals can rely on.
Context Therapeutics Inc. has received FDA clearance of its IND application for CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody.
Eluminex Biosciences Ltd. announced the FDA’s acceptance of their IND application for EB-105, a trispecific fusion antibody targeting vascular endothelial growth factor A (VEGF-A, and isomers), VEGF-B, placental growth factor (PlGF), angiopoietin-2 (Ang-2) and interleukin-6 receptor (IL-6R) for the treatment of diabetic macular edema (DME).
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
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