New Drug Application News and Research

RSS

Pig kidney xenotransplantation offers a bridge for patients awaiting human donor kidneys

In January 2026, Tim Andrews, who had received a genetically edited pig kidney in January 2025, became the recipient of a human kidney.

3 Sep 2026

FDA grants fast track designation to Insilico's AI-designed mesothelioma drug candidate

Insilico Medicine ("Insilico"; HKEX: 3696), a clinical-stage generative artificial intelligence (AI)-driven drug discovery company, today announced that ISM6331, a novel, potential best-in-class pan-TEAD inhibitor driven by Insilico's proprietary AI, has received Fast Track Designation (FTD) from the U.S.

29 Jul 2026

Once-nightly oral pill helps control obstructive sleep apnea

A once-nightly oral pill helped control obstructive sleep apnea in a large, phase 3 clinical trial presented at the 2026 ATS International Conference.

18 May 2026

OYE Therapeutics doses first subject in bridging study of intravenous caffeine formulation

OYE Therapeutics Inc., a clinical-stage biotechnology company developing therapies for perioperative and emergency medicine, announced that the first subject has been dosed in its scientific bridging study evaluating OYE-101.

7 Apr 2026

Researchers discover a way to breach cancer’s impenetrable fortress

Researchers at Case Western Reserve University have discovered a way to breach one of cancer's most stubborn defenses: the impenetrable fortress that solid tumors build around themselves.

18 Feb 2026

CIRM awards $7.4 million to advance stem cell-based gene therapy for Friedreich's ataxia

The California Institute for Regenerative Medicine (CIRM) has awarded $7.4 million to support a University of California San Diego team developing a first-of-its-kind stem cell-based gene therapy for Friedreich's ataxia, a rare inherited neurodegenerative disease that causes progressive loss of coordination, muscle strength, heart function and overall mobility.

8 Jan 2026

UC Irvine receives funding for clinical trial of neural stem cell therapy for Huntington's disease

Leslie M. Thompson, Donald Bren Professor of psychiatry and human behavior as well as neurobiology and behavior at the University of California, Irvine, has received an $11,999,933 grant from the California Institute for Regenerative Medicine for an unprecedented clinical trial of a novel neural stem cell therapy for Huntington's disease.

12 Dec 2025

New drug-releasing system eliminates tumors in 82% of high-risk bladder cancer patients

A new drug-releasing system, TAR-200, eliminated tumors in 82% of patients in a phase 2 clinical trial for individuals with high-risk non-muscle-invasive bladder cancer whose cancer had previously resisted treatment.

13 Aug 2025

Injecting medicine into amniotic fluid shows promise for treating genetic disorders

Injecting medicine into the amniotic fluid staves off progression of spinal muscular atrophy in utero.

14 May 2025

IL-12 cytokine factory demonstrates success in targeting hard-to-treat cancers

A team of researchers from the Rice Biotech Launch Pad at Rice University has developed an implantable "cytokine factory" that safely triggers potent immune responses against hard-to-treat cancers, including metastatic melanoma, pancreatic and colorectal tumors.

8 Apr 2025

Rutgers researchers develop promising new oral antiviral for COVID-19

Rutgers Health researchers have developed an oral antiviral drug candidate for COVID-19 that could overcome major limitations of Paxlovid, currently the most prescribed oral treatment.

3 Apr 2025

LGM Pharma invests $6 M in U.S. drug manufacturing capabilities for liquids, suspensions, semi-solids, and suppositories

LGM Pharma, a leading provider of tailored API and CDMO services for the full drug product lifecycle, today announced an investment of over $6 million to expand its Rosenberg, Texas manufacturing facility as part of its Phase I CDMO growth strategy.

13 Mar 2025

Vanderbilt researchers aim to use AI to develop antibody therapies for any target

An ambitious project led by Vanderbilt University Medical Center investigators aims to use artificial intelligence technologies to generate antibody therapies against any antigen target of interest.

8 Mar 2025

New nasal vaccine for COVID-19 set to begin clinical trial in the U.S.

A nasal vaccine for COVID-19 – based on technology developed at Washington University in St. Louis – is poised to enter a phase 1 clinical trial in the U.S. after an investigational new drug application from Ocugen, Inc. was approved by the Food and Drug Administration (FDA). Ocugen, a U.S.-based biotechnology company, licensed the innovative technology from WashU in 2022.

5 Feb 2025

New Drug Application News and Research

Pig kidney xenotransplantation offers a bridge for patients awaiting human donor kidneys

FDA grants fast track designation to Insilico's AI-designed mesothelioma drug candidate

Once-nightly oral pill helps control obstructive sleep apnea

OYE Therapeutics doses first subject in bridging study of intravenous caffeine formulation

Researchers discover a way to breach cancer’s impenetrable fortress

CIRM awards $7.4 million to advance stem cell-based gene therapy for Friedreich's ataxia

UC Irvine receives funding for clinical trial of neural stem cell therapy for Huntington's disease

New drug-releasing system eliminates tumors in 82% of high-risk bladder cancer patients

Injecting medicine into amniotic fluid shows promise for treating genetic disorders

IL-12 cytokine factory demonstrates success in targeting hard-to-treat cancers

Rutgers researchers develop promising new oral antiviral for COVID-19

LGM Pharma invests $6 M in U.S. drug manufacturing capabilities for liquids, suspensions, semi-solids, and suppositories

Vanderbilt researchers aim to use AI to develop antibody therapies for any target

New nasal vaccine for COVID-19 set to begin clinical trial in the U.S.

Researchers launch startup to revolutionize targeted drug delivery using milk exosomes

Ohio State's novel DHODH inhibitor enters first human trials

New insights into the pharmacokinetics of remdesivir in treating SARS-CoV-2 in pregnant women

Purdue researcher receives $2.4 million NIH grant to combat antimicrobial resistance in lung infections

Injectable hydrogel can mitigate right ventricular heart failure

Three new studies show low-dose atropine can help slow myopia in children

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Applications Engineer

Latest News