Pierre Fabre Pharmaceuticals, Inc. (PFP), announces it has aligned with FDA on a potential path forward for resubmission of the BLA for tabelecleucel, an...
Jakafi XR is a once-daily, film-coated, extended-release formulation of Jakafi®(ruxolitinib) Once-daily Jakafi XR was shown to provide consisten...
InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the pr...
U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for trenibotulinumtoxinE (TrenibotE) related to manufacturing processes; ...
Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indica...
Received FDA Fast Track Designation for pevifoscorvir sodium for the treatment of chronic hepatitis B virus infection HBeAg- cohort sample size increa...
FDA grants Fast Track Designation for Daretabart (hu1418K322A), recognising the significant unmet medical need in high-risk neuroblastoma and enabling ...
Partnering with Parent Project Muscular Dystrophy to ensure timely access to the trial for eligible patients ~15,000 children are living with DMD in the...
EPO Greenlights Claims Covering Preventative use of therapy targeting 5-HT4 Pathway and Expands Silo Pharma IP Portfolio Silo Pharma, Inc. (Nasdaq: SILO...
FDA Fast Track designation supports accelerated development and expedites regulatory review Norovirus is responsible for an estimated 685 million glob...
BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary dis...
Approval is based on 96-week data from 2 pivotal trials showing majority of EYLEA HD patients maintained their visual and anatomic improvements with exte...
From a basement-born idea to a publicly traded biotech advancing late-stage clinical trials, Lew Bender’s journey reflects both scientific persistenc...
Company has already submitted proposed confirmatory trial for FDA review, as required under accelerated approval pathway Company plans to submit...
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