Investigational New Drug - Search News

Targeted Oncology · 1d

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 cell lung cancer and other solid tumor indications.

MarketWatch · 2d

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.

Business Insider · 2d

Solid Biosciences's IND For Gene Therapy To Treat Friedreich's Ataxia Gets FDA Clearance

Tuesday announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SGT-212 for the treatment of Friedreich's ataxia (FA), a degenerative disease caused by insufficient levels of the frataxin protein.

Targeted Oncology · 1d

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 and safety with atezolizumab and bevacizumab in frontline treatment.

TipRanks on MSN · 2d

Solid Biosciences gains 12% to $4.40 on FDA clearance of SGT-212 IND

EST Solid Biosciences (SLDB) gains 12% to $4.40 on FDA clearance of SGT-212 IND Published first on TheFly – the ultimate source for

2d

MBX Biosciences' Investigational Drug For Weight Loss Surgery-Related Low Blood Sugar Shows Encouraging Action

MBX Biosciences Inc. (NASDAQ:MBX) revealed results from its Phase 1 single ascending dose and multiple ascending dose trial ...

2d

Shanghai Junshi’s JS212 Drug Application Accepted, Boosting Cancer Therapy Pipeline

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Contract Pharma3d

Asieris & CDC Sign Investigational Drug Supply Agreement for APL-1202

Nitroxoline has not been approved by the FDA, and its use is therefore considered investigational. FLA patients will receive ...

GlobalData on MSN3d

Oculis’ acute optic neuritis therapy trial meets primary endpoint

The trial is designed to assess the tolerability, efficacy, and safety of two different dosages of the therapy.

2d

Recursion announces two oncology drugs advancing to clinical trials

Recursion announced that the UK Medicines and Healthcare Products Regulatory Agency has cleared a clinical trial application for a Phase 1 ...

First subjects dosed in Phase-1 clinical trial of Cognitive Disorder drug SUVN-I6107: Suven Life Sciences

Hyderabad: Suven Life Sciences, a clinical stage biopharmaceutical company discovering and developing novel medicines to ...

2don MSN

FDA issues draft guidance on developing weight loss drugs

The U.S. FDA has released a new draft guidance for drugmakers to aid them in developing new treatments for obesity. The new ...

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