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Proteostasis Therapeutics president and CEO Meenu Chhabra said: "This is the second important regulatory designation PTI-428 has been granted from the FDA this week, highlighting our amplifier’s potential to

The trial was evaluating the safety and efficacy of the investigational therapy in ambulatory and non-ambulatory children and adolescents with the genetic disorder. According to Solid Biosciences, the

Results from the second of two pivotal Phase 3 studies demonstrated at month six that elagolix (300 mg twice daily), in combination with low-dose hormone (add-back) therapy (estradiol

The Placing was completed at a subscription price of €9.00 per share and represented 14.8% of the issued share capital of the Company prior to the transaction. The

The company’s supplemental Biologics License Application (sBLA), which has been accepted by the regulator, is seeking approval for treating patients whose cervical cancer had progressed on or after

In May 2017, the FDA turned down VR315, a generic version of GlaxoSmithKline’s asthma/COPD inhaler Advair Diskus. During that time, the companies received a complete response letter from the FDA.

The company said that it has received final minutes from a February 2018 Type C meeting held with the Division of Neurology Products, United States Food and Drug

This exploratory analysis from the CANVAS Program was featured as a late-breaking oral presentation at the American College of Cardiology’s 67th Annual Scientific Session (abstract #407-10) and was

PF-04958242, which is ready for phase 2b development, is an AMPA receptor potentiator, developed for treating cognitive impairment associated with schizophrenia (CIAS). AMPA receptors restore excitatory synaptic transmission process