FDA
Excerpt from the Press Release: SAN DIEGO, Oct. 14, 2022 /PRNewswire/ — Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on oncology, announced today that it has received clearance from the US Food and Drug Administration (FDA) to commence Phase I studies with PT217, its anti-Delta-like ligand 3 (DLL3)/anti-Cluster of differentiation 47 (CD47)…
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Next Generation Senza® HFX iQ™ is the First and Only SCS System that Uses Artificial Intelligence to Optimize and Maintain Pain Relief Using Each Patient’s Response Excerpt from the Press Release: REDWOOD CITY, Calif., Oct. 12, 2022 /PRNewswire/ — Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the…
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Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initiate a Phase I/Ib clinical trial (COVALENT-102) of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or pancreatic…
Read More Autologous TIL therapy enhanced with Lyell’s Epi-R™ reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function Phase 1 trial to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer Initial data presentation expected…
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Excerpt from the Press Release: BERWYN, Pa., Oct. 6, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has authorized the Phase 2/3 clinical study of buntanetap in moderate Alzheimer’s Disease (AD). Following the…
Read More AHFIRM enrollment surpasses 200 of the planned 300 AH patients Enrollment completion now anticipated in Q2 2023 Excerpt from the Press Release: CUPERTINO, Calif., Oct. 6, 2022 /PRNewswire/ — DURECT Corporation (Nasdaq: DRRX), a biopharmaceutical company focused on developing epigenetic regulator programs for the treatment of acute organ injury and chronic liver diseases, today announced…
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Enrollment continues in clinical trial of MB-106 under Mustang’s IND; next data disclosure anticipated 4Q 2022 Ongoing clinical trial of MB-106 at Fred Hutch continues to demonstrate high efficacy, durable responses, and favorable safety profile across wide range of hematologic malignancies Excerpt from the Press Release: WORCESTER, Mass., Oct. 06, 2022 (GLOBE NEWSWIRE) — Mustang…
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Initiation of Phase 1/2a Clinical Trial Expected to Occur in Q4 2022 Excerpt from the Press Release: CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company that aims to create medicines for all patients with solid tumors driven by RAS mutations and other MAPK pathway activation events, today announced…
Read More First once-weekly transdermal system offering continuous delivery of donepezil, most-commonly prescribed Alzheimer’s dementia drug Broadens Corium’s CNS drug portfolio Excerpt from the Press Release: BOSTON, Sept. 29, 2022 /PRNewswire/ — Corium, Inc., a fully-integrated biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today that ADLARITY (donepezil transdermal system)…
Read More Excerpt from the Press Release: SAN FRANCISCO, CA / ACCESSWIRE / September 29, 2022 / Napo Pharmaceuticals, Inc. (“Napo”), the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today announced the activation by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for Napo’s NP-300, a novel…
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