Better Therapeutics (Nasdaq:BTTX) shares ticked up on fourth-quarter results and projections for its flagship product in 2023. The company’s quarterly results come on the heels of a 35% headcount reduction. Better Therapeutics said the headcount cut comes as part of a cost reduction initiative. It aims to improve its cash runway and “focus on the long-term success […]
Food & Drug Administration (FDA)
FDA approves over-the-counter Narcan nasal spray
The FDA announced today that it approved Narcan 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter, nonprescription use. Narcan rapidly reverses the effects of opioid overdose and remains the standard treatment for such an overdose. Approval allows direct-to-consumer sales in places like drug stores, convenience stores and more. The FDA nod comes about six […]
Surmodics targets FDA premarket approval for drug-coated balloon in Q4
Surmodics (Nasdaq:SRDX) announced today that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a proposed approach to submit an amended premarket approval application for SurVeil. In January, the FDA indicated that Surmodics’ SurVeil PMA application is not approvable. The FDA said it […]
Analysts receive update on Embecta insulin patch pump progress
BTIG analysts Marie Thibault and Sam Eiber met with Embecta (Nasdaq:EMBC) executives last week and received an update on the company’s current position. Thibault and Eiber met with Embecta CFO Jake Elguicze and Head of Investor Relations Pravesh Khandelwal. Among a series of updates, the BTIG report said Embecta expects a “transitional period” in the […]
Bigfoot Biomedical takes next steps for its holistic diabetes management platform
After executing a significant IP sale, Bigfoot Biomedical looks to double down on its diabetes management platform. Less than two years ago, Bigfoot Biomedical launched its Bigfoot Unity platform in some U.S. states. CEO Jeffrey Brewer last year called it a “transformational attempt” to simplify CGMs and the data they produce. It features a smart […]
FDA clears Abbott FreeStyle Libre for automated insulin pump integration
Abbott (NYSE:ABT) announced today that the FDA cleared its FreeStyle Libre 2 and FreeStyle Libre 3 for automated insulin delivery (AID) integration. AID systems help people manage daily diabetes care by automatically adjusting and administering the insulin delivered by an insulin pump based on real-time glucose data from their FreeStyle Libre 2 or FreeStyle Libre […]
Bigfoot Biomedical wins FDA clearance for Bigfoot Unity Android app
Bigfoot Biomedical announced today that it received FDA 510(k) clearance for the Android version of its Bigfoot Unity mobile app. Milpitas, California-based Bigfoot received FDA clearance for its diabetes management platform in May 2021. Its initial rollout featured compatibility with iOS devices. The first-of-its-kind system includes connected smart pen caps designed to recommend insulin doses […]
Glaukos submits FDA New Drug Application for iDose TR drug-eluting implant
Glaukos (NYSE:GKOS) announced today that it submitted a New Drug Application (NDA) to the FDA for its iDose TR implant. Aliso Viejo, California-based Glaukos designed iDose TR as a micro-invasive intraocular implant. It continuously delivers therapeutic levels of a proprietary formulation of travoprost from within the eye over extended periods of time. Once all travoprost […]
FDA committee unanimously votes in favor of over-the-counter Narcan from Emergent BioSolutions
Emergent BioSolutions (NYSE:EBS) announced today that its over-the-counter Narcan (naloxone HCl) nasal spray received unanimous approval from governing bodies. The vote came from the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. A total of 19 voters decided in favor of the benefit-risk profile for Narcan. The voters support […]
Tidepool Loop automated insulin delivery system wins FDA clearance
Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin delivery (AID) system. Palo Alto, California-based Tidepool is a non-profit diabetes data management group. It created the hybrid, closed-loop AID app for compatibility with multiple insulin pumps and continuous glucose monitors. The company announced collaborations in the past that include […]
