(RTTNews) - Humacyte, Inc. (HUMA), a biotechnology company, Tuesday announced its plan to file an Investigational New Drug or IND application with the U.S. FDA in 2025 to support a first-in-human ...

(RTTNews) - PDS Biotech (PDSB), a late-stage immunotherapy company focused on cancer treatments, announced Thursday that the U.S. Food and Drug Administration or FDA has cleared its Investigational ...

As part of the Company’s strategic shift into the OTC marketplace, it has withdrawn its investigational new drug application for XYNGARI with FDA.

BOSTON, Mass, April 01, 2025 (GLOBE NEWSWIRE) -- Radiance Biopharma, Inc. (“Radiance” or the “Company”), a clinical stage biopharmaceutical company advancing Antibody Drug Conjugates (‘ADCs’), today ...

In August 2024, Bin Xia Yang, a portfolio director at the pharmaceutical company Axcynsis Therapeutics, geared up to move the company’s new tumor-fighting antibody-drug conjugate into clinical trials.

Pulmatrix (PULM) received a study may proceed letter for a Phase 2 Study to Evaluate PUR3100, an orally inhaled dry powder formulation of dihydroergotamine ("DHE") in the treatment of acute migraine ...

The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen receptor T-cell therapy that may bypass lymphodepletion, paving the way for a phase 1 trial in ...

EVM14, an mRNA cancer vaccine, received FDA clearance for investigational new drug application, advancing Everest's mRNA technology to global clinical trials. Preclinical studies showed EVM14 induces ...