Drug Research
FDA Approves Daiichi Sankyos TURALIO pexidartinib for the Treatment of Select Patients with TGCT a Rare and Debilitating Tumor
Daiichi Sankyo Company, Limited announced that the U.S. FDA approved TURALIO™ (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
TGCT is...
News
Amicus Therapeutics Receives Marketing Authorization for Galafold for Fabry Disease in Argentina
Amicus Therapeutics announced that the Agency of Medicines, Food and Medical Devices (ANMAT) in Argentina has granted approval for the first-in-class, oral small molecule pharmacological chaperone Galafold® (migalastat), as a monotherapy for the treatment of people aged 16 years...
Clinical Trials
Amicus Announces Positive Interim Clinical Data for AAV Gene Therapy in Children with CLN6 Batten Disease
Amicus Therapeutics announced positive interim results from its CLN6 Batten disease gene therapy program licensed from the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s Hospital. AWRI is conducting the ongoing Phase 1/2 clinical study of a single one-time...
Clinical Trials
GlycoMimetics Reports Top-line Results From Pfizers Phase 3 Clinical Trial Evaluating Rivipansel in Sickle Cell Disease
GlycoMimetics, Inc. reported that Pfizer Inc. announced that the Phase 3 Rivipansel (GMI-1070): Evaluating Safety, Efficacy and Time to Discharge (RESET) pivotal study did not meet its primary or key secondary efficacy endpoints.
The objective of the trial was to...
Drug Research
LexaGene Approved by CDC and FDA Antibiotic Resistance Isolate Bank to Receive Samples
LexaGene Holdings, Inc, a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers, announced that it has been recognized by the Centers for Disease Control and Prevention (CDC) and the FDA Antibiotic Resistance (AR) Isolate...
News
TempControl Launches Widebody Service to MEX Announces Network Expansion
United Cargo announced an enhancement to its specialized service for pharmaceuticals, healthcare material and other commodities requiring temperature-sensitive transport. Through an interline agreement with all-cargo carrier AeroUnion, widebody TempControl service is now available to Mexico City International Airport (MEX).
TempControl...
News
Signant Health Senior Vice President Dr. David Daniel Honored in PharmaVoice 100
Signant Health (formerly CRF Health and Bracket) announces that its Senior Vice President, Dr. David Daniel, has been selected by PharmaVOICE as one of the top 100 most inspiring people within the life sciences sector. Dr. Daniel was selected...
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