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Spiral Therapeutics, Inc. (“Spiral”), a clinical-stage pharmaceutical company leading the way in therapies for inner ear disorders, today announced a strategic partnership with the Vestibular Disorders Association (VeDA).

Spiral Therapeutics, Inc., a clinical-stage company focused on delivering therapies for inner ear disorders, announced a new round of financing led by Esperante Ventures and Ferring Ventures SA.

Spiral Therapeutics, Inc. (“Spiral”), a clinical-stage company focused on delivering therapies for inner ear disorders, announced today the completion of its acquisition of selected assets from Otonomy, Inc.

Sequel, a startup, dedicated to engineering better health and wellness experiences for women, today announced that its breakthrough spiral tampon has received approval from the United States Food and Drug Administration (FDA) as a medical device.

Spiral Therapeutics, Inc. (“Spiral”), a clinical-stage company focused on delivering therapies for inner ear disorders, today announced that the Company recently completed an $8.25M financing, with new proceeds that will fund the continuing development of its lead candidate, SPT-2101, for the treatment of inner ear inflammation.

We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system

Intratech Medical, developer of the Booster™ spiral balloon therapy for the treatment of AMI patients, announced the successful enrollment of two patients in a multi-center first in human study to assess the safety and technical performance of their Booster balloon in the treatment of patients undergoing coronary catheterization.

The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical trial—including a dosing error for govorestat—claims that the company said it had already addressed.

After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.