Streetbeat News

Regulatory

TFX

Teleflex's Arrow EZ-IO Needle, a component of the Arrow EZ-IO Intraosseous Vascular Access System, has received 510(k) clearance from the FDA for MR Conditional Labeling. The needle has a patented diamond tip for fast and precise insertion and can be used when intravenous access is difficult or impossible.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2023 | 10:35 am

GSK

The FDA has accepted GSK's supplemental marketing application for Jemperli (dostarlimab) plus chemotherapy for adult patients with mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer. The PDUFA date is set for 23 September under priority review.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2023 | 10:19 am

F

Ford Motor Co is recalling over 125,000 hybrid electric vehicles due to an increased risk of fire. The affected vehicles include certain 2020-2023 Escape, 2022-2023 Maverick, and 2021-2023 Corsair models. Ford expects a remedy to be available by Q4.

Portfolio Pulse from Anan Ashraf

June 06, 2023 | 10:04 am

BCLI

BrainStorm Cell Therapeutics announced an FDA Advisory Committee meeting scheduled for September 27, 2023, to review the Biologics License Application (BLA) for NurOwn, its investigational stem cell therapy for amyotrophic lateral sclerosis (ALS). The Prescription Drug User Fee Act (PDUFA) action date is targeted for December 8, 2023.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2023 | 10:02 am

BTCUSD

CNBC's Mad Money host Jim Cramer labels Binance a 'sham' amid the SEC lawsuit against the cryptocurrency exchange and its founder Changpeng Zhao for alleged securities violations. Cramer warns crypto investors to work in overdrive as the SEC's case highlights systemic issues within the industry.

Portfolio Pulse from Mehab Qureshi

June 06, 2023 | 9:50 am

FENC

Fennec Pharmaceuticals has received marketing authorization from the European Commission for Pedmarqsi, the first and only approved therapy in the EU for preventing hearing loss in pediatric oncology patients aged 1 month to <18 years. Pedmarqsi was granted authorization under the paediatric-use marketing authorization (PUMA), which includes 8 years plus 2 years of data and market protection.

Portfolio Pulse from Benzinga Newsdesk

June 06, 2023 | 9:45 am

BNO

VDE

Oil prices slid on Tuesday due to concerns over the global economy, overshadowing Saudi Arabia's unexpected production cut announcement. The fall in oil prices is unfavorable for Saudi Arabia, which requires oil prices above $80 per barrel to balance its budget, according to an IMF report.

Portfolio Pulse from Bhavik Nair

June 06, 2023 | 9:09 am

BTCUSD

The cryptocurrency market tumbled following the SEC's lawsuit against Binance, resulting in over $300 million of losses in liquidations within 24 hours. Long positions accounted for $274 million of the losses, marking the largest level of long liquidations in at least three months. Bitcoin traders were hit the hardest, with losses totaling almost $111 million.

Portfolio Pulse from Mehab Qureshi

June 06, 2023 | 6:06 am

DOGEUSD

The SEC has charged Binance and its founder Changpeng Zhao for alleged securities violations, prompting reactions from crypto community figures like Jack Dorsey and Dogecoin co-founder Billy Markus. The outcome of the lawsuit may impact the future of cryptocurrencies.

Portfolio Pulse from Mehab Qureshi

June 06, 2023 | 4:46 am

BTCUSD

ETHUSD

Ethereum co-founder Jeffrey Wilcke transferred 22,000 ETH ($41.1 million) to Kraken exchange hours after the SEC filed charges against Binance for alleged securities violations. Wilcke's address still holds over 150,000 ETH ($280 million).

Portfolio Pulse from Mehab Qureshi

June 06, 2023 | 3:41 am