NDA

Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR™-310 in Relapsed/Refractory B-cell NHL

04/12/2024

Company advances towards their second clinical trial for SynKIR™ platform treating patients with Diffuse Large B Cell Lymphoma and other B-cell Non-Hodgkin Lymphoma subtypes who are relapsed or refractory after standard of care, including CAR T therapies Excerpt from the Press Release: PHILADELPHIA, April 3, 2024 /PRNewswire/ — Verismo Therapeutics, a clinical-stage CAR T company developing…

Read More

Strand Therapeutics Receives IND Clearance for Programmable mRNA Therapy STX-001 to Treat Solid Tumors

01/26/2024

Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Strand Therapeutics, the programmable mRNA company developing breakthrough therapies for cancer and other diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1, first-in-human trial of STX-001, a multi-mechanistic synthetic self-replicating mRNA technology that expresses an…

Read More

Biomea Fusion Announces FDA Clearance of Investigational New Drug (IND) Application for BMF-219 in Type 1 Diabetes

10/12/2023

BMF-219 is a novel covalent menin inhibitor designed to regenerate insulin-producing beta cells with the aim to cure type 1 diabetes Excerpt from the Press Release: REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to…

Read More

Aligos Therapeutics Announces IND Clearance for NASH lead, ALG-055009

10/02/2023

– Phase 2a NASH protocol on track to be submitted to the IND in Q4 2023, enrollment expected to begin in Q1 2024 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to…

Read More

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) application for VNT-101, a novel direct-acting antiviral against Influenza A virus

09/28/2023

Excerpt from the Press Release: OAKLAND, Calif., Sept. 21, 2023 /PRNewswire/ — Via Nova Therapeutics, Inc., a biotechnology company focused on discovering and developing therapeutics to treat viral infections with significant unmet medical need, today announced the clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its…

Read More

AusperBio Announces FDA Clearance of IND Application of AHB-137 in Chronic Hepatitis B Treatment

08/31/2023

Excerpt from the Press Release: SAN FRANCISCO, Aug. 25, 2023 /PRNewswire/ — AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotech company committed to advancing antiviral therapies and vaccines, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced the U.S. Food and Drug…

Read More

Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials

08/28/2023

Excerpt from the Press Release: BOSTON, MASSACHUSETTS, Aug. 24, 2023 (GLOBE NEWSWIRE) — BIOXYTRAN, INC. (BIXT), (the “Company”), a clinical stage biotechnology company developing oral drugs to treat COVID-19 and other viral diseases, announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA), to…

Read More

C4 Therapeutics Announces FDA Clearance of Investigational New Drug Application for CFT8919, an Orally Bioavailable BiDAC™ Degrader Targeting EGFR L858R for Non-Small Cell Lung Cancer

07/17/2023

Excerpt from the Press Release: WATERTOWN, Mass., July 05, 2023 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the U.S. Food and Drug Administration (FDA)…

Read More

Alzheimer’s drug Leqembi gets full FDA approval. Medicare coverage will likely follow

07/13/2023

Excerpt from the Press Release: The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer’s disease. The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who…

Read More

Reviva Pharmaceuticals Announces Intent to File an IND for Brilaroxazine in Psoriasis After Promising Preclinical Data

05/19/2023

Brilaroxazine topical liposomal-gel formulation (brilaroxazine lipogel) demonstrated proof-of-concept efficacy in the imiquimod-induced psoriatic mouse model IND submission for brilaroxazine lipogel in psoriasis expected in 2024 Reviva has filed composition of matter patent for brilaroxazine-lipogel and a separate patent for use in the treatment of psoriasis Excerpt from the Press Release: CUPERTINO, Calif., May 11, 2023…

Read More