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.
Emerging Clinical-Stage Neuroscience Company Nuvie Bio Announces Positive Phase 1 Data with its Lead Migraine Program
Nuvie Bio, a new clinical-stage biopharmaceutical company dedicated to addressing the most pressing unmet medical needs in migraine and related neurological diseases, announced completion of a ...
Magdalena Biosciences, a Joint Venture Between Jaguar Health and Filament Health, to Present January 12 at the Annual Neuroscience Innovation Forum
Magdalena aiming to submit Investigational New Drug (IND) application in early 2025 to the FDA for a next-generation psychoactive prescription ...
Quanta Announces IND Clearance by U.S. FDA for QTX3544, an Oral G12V-Preferring Multi-KRAS Inhibitor, and Other Pipeline Updates
Initiated combination portion of Phase 1 clinical trial of QTX3046, an oral KRASG12D-selective dual ON/OFF state allosteric inhibitor, with the EGFR inhibitor cetuximab – – Phase 1 clinical trial of ...
FDA issues draft guidance on developing weight loss drugs
New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments.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.
Solid Biosciences's IND For Gene Therapy To Treat Friedreich's Ataxia Gets FDA Clearance
SGT-212 is the company's novel, AAV-based FA gene therapy candidate designed to deliver full-length frataxin via systemic intravenous (IV) infusion as well as direct intradentate nuclei (IDN) infusion ...
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Mineralys Therapeutics Announces Phase 2 Clinical Trial of Lorundrostat for Obstructive Sleep Apnea in Patients with Hypertension
Between 30-50% of adults with hypertension have OSA, and this number increases to between 70-80% in adults with resistant hypertension. Additionally, untreated moderate-to-severe OSA increases the ...
Suven Life shares rise 11% on progress in clinical trial of cognitive disorder drug
The company announced that the first subjects have been dosed in a Phase-1 clinical trial of SUVN-I6107 in the USA.
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Arch-backed Tenvie unveils with $200M and a neuro pipeline with assets from Denali
Tenvie Therapeutics has unveiled with $200 million and the goal of transforming the neurological treatment landscape, nabbing ...
Solid Biosciences stock jumps 11% post-market on FDA update
Shares of Solid Biosciences (NASDAQ:SLDB) jumped 11% post-market after the company said the FDA had cleared an ...
Ensysce Biosciences Issues Annual Shareholder Letter
~ FDA Breakthrough Therapy designation received for PF614-MPAR ~ ~ PF614-MPAR second clinical trial initiated ~ ~ Lead clinical candidate identified for OUD program ~ ~ PF614 Phase 3 trial poised to ...
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Celltrion to reveal four-year road map at J.P. Morgan Healthcare Conference
Celltrion will reveal its dual-track strategy to juggle the development of both biosimilars and original drugs at the J.P. Morgan Healthcare Conference.