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Regulatory

NDRA

ENDRA Life Sciences Inc.'s De Novo request for the TAEUS liver system has advanced to the substantive review stage with the U.S. Food and Drug Administration (FDA). The TAEUS system is a proprietary device for non-invasive assessment of fatty liver tissue. The FDA aims to make a decision about a De Novo request in 150 review days. If granted, it will strengthen TAEUS' competitive position.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:19 pm

SPY

The ADP Nonfarm Employment Change for August was reported at 177K, lower than the estimated 195K and significantly below the prior figure of 324K.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:15 pm

MCHP

Microchip Technology's PolarFire FPGAs have been successfully reviewed by the UK Government's National Cyber Security Centre (NCSC) for their Single-Chip Crypto Design Flow. The review confirms the security of systems relying on these devices, reinforcing Microchip's commitment to security. The PolarFire FPGAs implement Microchip's industry-leading security architecture to protect intellectual property, secure data, and secure supply chains.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:11 pm

AGR

Avangrid, Inc. (NYSE:AGR) has announced a pilot project with LineVision, Inc. to increase capacity on its transmission lines for renewable energy in New York state. The project will use advanced monitoring to provide real-time data on where additional power can flow through the existing transmission infrastructure. This could aid in linking more renewable energy resources into New York's electrical grid and supporting the state's clean energy goals. The project is funded through round two of NYSERDA's Future Grid Challenge program.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:08 pm

CRMD

CorMedix Inc. (NASDAQ:CRMD) has been granted a new U.S. patent for the composition of a catheter lock solution, DefenCath, aimed at preventing infection and reduced blood flow in central venous catheters. The patent extends the company's intellectual property protection until April 15, 2042. The company also expects DefenCath to be eligible for 10.5 years of statutory marketing exclusivity in the U.S. upon potential FDA approval.

Portfolio Pulse from Happy Mohamed

August 30, 2023 | 12:04 pm

ZLAB

The Center for Drug Evaluation of National Medical Products Administration has granted Breakthrough Therapy Designation to Zai Lab's Repotrectinib. The drug is intended for advanced solid tumors with NTRK gene fusion in patients who have progressed after TRK Tyrosine Kinase Inhibitor treatment.

Portfolio Pulse from Benzinga Newsdesk

August 30, 2023 | 11:39 am

OTLK

Outlook Therapeutics Inc's (NASDAQ:OTLK) shares are plummeting after the FDA issued a complete response letter regarding the company's investigational ophthalmic formulation, ONS-5010. The FDA acknowledged the safety and efficacy of the drug but could not approve the application due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence. The company's shares are down 73.1% at $0.38 during the premarket session.

Portfolio Pulse from Vandana Singh

August 30, 2023 | 11:39 am

BTCUSD

ETHUSD

SPY

The article covers a range of topics including stock movements, crypto news, politics, tech, electric vehicles, financials, and industrials. Key highlights include Peter Schiff's comments on Bitcoin ETFs, Grayscale's court victory over SEC, Walmart's partnership with Google's drone unit, and Goldman Sachs' acquisitions using Chinese state funds.

Portfolio Pulse from Akanksha Bakshi

August 30, 2023 | 11:34 am

ABEO

Abeona Therapeutics Inc. (NASDAQ:ABEO) has announced its intention to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EB-101, its investigational autologous, engineered cell therapy, for patients with recessive dystrophic epidermolysis bullosa (RDEB). This follows a successful pre-BLA meeting with the FDA.

Portfolio Pulse from Benzinga Newsdesk

August 30, 2023 | 11:33 am

IFRX

InflaRx's Marketing Authorization Application (MAA) for Vilobelimab, a treatment for critically ill COVID-19 patients, is currently under review by the European Medicines Agency (EMA).

Portfolio Pulse from Benzinga Newsdesk

August 30, 2023 | 11:32 am