Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Non-Muscle Invasive Bladder Cancer (SURF302)
TYRA appoints urologic oncologist, Erik Goluboff, M.D., as SVP, Clinical Development to lead NMIBC- -First patient expected to be dosed in SURF302 in Q2 2025- CARLSBAD ...
FiercePharma2h
Breaking down the 55 new drug approvals of 2024
A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods g | ...
Hosted on MSN22h
Suven doses first subjects in trial of SUVN-I6107 for cognitive disorders
India-based Suven Life Sciences has announced the dosing of the first subjects in its Phase I clinical trial of SUVN-I6107 to ...
Solid Biosciences Outpaces Competitors In Duchenne Gene Therapy Development (CORRECTED)
Solid Biosciences advances gene therapies for muscular and cardiac diseases, gaining FDA clearance for SGT-212 and targeting ...
Targeted Oncology1d
FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...
Targeted Oncology1d
Amezalpat Gains FDA Orphan Drug Status in HCC
The FDA granted orphan drug designation to amezalpat in hepatocellular carcinoma based on phase 1b/2 data showing efficacy ...
marketinference1d
FDA Clears Mineralys Therapeutics' IND for OSA and Hypertension Trial
Mineralys Therapeutics, Inc. (NASDAQ: MLYS) has announced the clearance of its investigational new drug (IND) application by ...
Hosted on MSN1d
SLDB Stock Up as FDA Clears IND for SGT-212 in Friedreich's Ataxia
Solid Biosciences Inc. SLDB announced that the FDA has cleared its investigational new drug (IND) application to begin ...
Quanta Announces IND Clearance by U.S. FDA for QTX3544, an Oral G12V-Preferring Multi-KRAS Inhibitor, and Other Pipeline Updates
Additionally, the Phase 1 clinical trial evaluating QTX3034, an oral G12D-preferring multi-KRAS inhibitor, as a monotherapy and in combination with cetuximab, continues to enroll patients, and data is ...
Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
FDA issues draft guidance on developing weight loss drugs
New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments. Read more here.