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etectRx Announces U.S. FDA Clearance of Novel Ingestible Event Marker prnasia
December 16, 2019
ID-Cap System Uses Advanced Wireless Technology to Reliably Track Ingestion Events
GIOSTAR in Process of FDA Approval for Type 2 Diabetes Clinical Trial americanpharmaceuticalreview
December 16, 2019
Global Institute of Stem Cell Therapy and Research (GIOSTAR) announced they are in the process of approval from the United States Food and Drug Administration (FDA) to ...
OrthoGrid Systems Receives FDA 510(K) Clearance for PhantomMSK Trauma Application americanpharmaceuticalreview
December 16, 2019
OrthoGrid Systems announces its newest application, PhantomMSK Trauma, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA).
Navigen Announces FDA Clearance of IND Application to Initiate First-in-Human Studies for CPT31 americanpharmaceuticalreview
December 16, 2019
Navigen announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) for the initiation of a Phase I study in healthy volunteers to ...
FDA Grants Accelerated Approval to Rare Duchenne Muscular Dystrophy Mutation Treatment americanpharmaceuticalreview
December 16, 2019
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have ...
FDA Grants VistaGen Fast Track Designation for Social Anxiety Disorder Treatment americanpharmaceuticalreview
December 16, 2019
VistaGen Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of the Company's PH94B neuroactive nasal spray for ...
Tetra Bio-Pharma Requests Meeting with FDA on Hepatocellular Carcinoma Drug americanpharmaceuticalreview
December 16, 2019
Tetra Bio-Pharma will be requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the drug development program for its Orphan Drug candidate HCC011 ...
FDA issues warning letter for misrepresentation of drug in advertisement europeanpharmaceuticalreview
December 16, 2019
Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.
FDA agrees to review Novartis’ sBLA of Xolair to treat nasal polyps pharmaceutical-technology
December 16, 2019
The US Food and Drug Administration (FDA) has agreed to review a supplemental biologics license application (sBLA) submitted by Novartis to seek approval for Xolair (omalizumab) to treat nasal polyps.
Sarepta’s DMD therapy Vyondys 53 secures FDA accelerated approval pharmaceutical-technology
December 16, 2019
Sarepta Therapeutics has secured accelerated approval from the US Food and Drug Administration (FDA) for Vyondys 53 (golodirsen) to treat duchenne muscular dystrophy (DMD) patients with ...

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