FDA
The interventional, multicenter, open-label Phase 2 basket trial will evaluate the safety and efficacy of milademetan in patients with MDM2-amplified advanced solid tumors Excerpt from the Press Release: NEWARK, Calif., Nov. 19, 2021 (GLOBE NEWSWIRE) — Rain Therapeutics Inc. (NasdaqGS: RAIN), (“Rain”), a late-stage company developing precision oncology therapeutics, today announced that the first patient…
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Primary endpoint data expected in Q1 2022 SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (“Better Therapeutics”; NASDAQ: BTTX), a prescription digital therapeutics company developing cognitive behavioral therapy to address the root causes of cardiometabolic diseases, today announced the completion of patient enrollment in its potentially pivotal study to evaluate the safety and efficacy of BT-001 for the…
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Excerpt from the Press Release: Every day, hundreds of thousands of new COVID-19 cases and thousands of new deaths are still being reported worldwide, creating a need for drugs that can combat the disease caused by SARS-CoV-2. Now, new research led by investigators at Harvard Medical School and Boston Children’s Hospital points to a well-known…
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New, Single-arm Phase 3 Study Expected to Initiate in Early 2022 Excerpt from the Press Release: PRINCETON, N.J.–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat urothelial and specialty cancers, is announcing at its virtual Spotlight Event being held today that, following recent discussions with the…
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COVAXIN™ (BBV152) was recently awarded Emergency Use Listing by the World Health Organization Pediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralizing antibody response as seen in a large adult Phase 3 clinical trial conducted in India COVAXIN™ (BBV152) uses same Vero Cell manufacturing platform as other childhood vaccines,…
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Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Synthekine Inc., an engineered cytokine therapeutics company, today announced it is advancing its IL-2 partial agonist, STK-012, into clinical investigation following clearance of its investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). Synthekine will evaluate STK-012 in a Phase 1a/1b, open-label, multi-center,…
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Chest radiograph without Auto Lung Nodule Detection (ALND) and chest radiograph with lung nodule marked. (Photo: Business Wire) Excerpt from the Press Release: DANVERS, Mass.–(BUSINESS WIRE)–NeuroLogica Corp. today announced it has received Food and Drug Administration (FDA) 510(k) clearance for its Auto Lung Nodule Detection (ALND) tool. The offering provides an on-device, computer-assisted detection (CADe)…
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Excerpt from the Press Release: SAN DIEGO, Oct. 28, 2021 /PRNewswire/ — HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study. The authorization to proceed enables the first testing in patients for whom…
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Designation provides expedited regulatory review of Exo-PDAC, a liquid biopsy assay, built on the company’s Verita™ platform to detect pancreatic ductal adenocarcinoma earlier in high-risk adults Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Biological Dynamics, Inc., a multiomics liquid biopsy company focused on detecting cancers at the earliest stages, today announced that the U.S. Food…
Read More Emergency Use Authorization (EUA) granted for individuals 65 years of age and older, and individuals ages 18 through 64 within certain high-risk groups FDA also authorized the use of Moderna’s booster dose following primary vaccination with other authorized or approved COVID-19 vaccines Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering…
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