Streetbeat News

Regulatory

DDD

3D Systems has received FDA clearance for its Monolithic Jetted Denture solution, a significant milestone in the dental industry. This approval allows the company to market its innovative denture solution in the United States, potentially boosting its market presence and revenue.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 12:31 pm

BTCUSD

ETHUSD

A trader named BasedBoi has placed a $200,000 bet on the Federal Reserve keeping interest rates unchanged at the upcoming meeting, despite market expectations of a rate cut. This bet contrasts with the CME Fedwatch tool's 100% probability of a rate cut. The decision has significant implications for the broader market, including digital assets like Bitcoin and Ethereum.

Portfolio Pulse from Murtuza Merchant

September 17, 2024 | 12:21 pm

AIMD

Ainos is set to begin a clinical study in Taiwan for VELDONA as a treatment for oral warts in HIV-positive patients, following its FDA orphan drug designation. The study will start at National Taiwan University Hospital in November 2024.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 12:11 pm

MDAI

Spectral AI plans to submit a De Novo request for its DeepView AI-Burn device to be classified as a Class II medical device by Q2 2025.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 12:05 pm

GLMD

INTC

SES

Intel shares rise 11% following a strategic collaboration with AWS to boost US chip manufacturing. SES AI shares surge 57% after announcing a collaboration with NVIDIA, Crusoe, and Supermicro on AI for scientific initiatives. Galmed Pharmaceuticals regains Nasdaq compliance.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 12:04 pm

BGNE

BeiGene announced that the Israeli Ministry of Health has approved TEVIMBRA (Tislelizumab) for use as a monotherapy in adult patients with unresectable or metastatic OESCC who have undergone prior systemic chemotherapy.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:46 am

BBIO

BridgeBio Pharma has received Breakthrough Therapy Designation from the FDA for its oral drug Infigratinib, which is under development for treating children with achondroplasia. This designation is intended to expedite the drug's development and regulatory review.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:32 am

CI

Express Scripts, a subsidiary of Cigna, has filed a lawsuit against the Federal Trade Commission (FTC) demanding the withdrawal of a report on pharmacy benefit managers (PBMs). This legal action could impact Cigna's operations and regulatory environment.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:22 am

GSK

Japan's Ministry of Health, Labour and Welfare has accepted GSK's new drug application for Blenrep in combination with other drugs for treating relapsed or refractory multiple myeloma.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:18 am

GRMN

Garmin has received certification for its G5000 integrated flight deck for the Cessna Citation XLS+ and XLS Gen2 aircraft. This certification marks a significant milestone for Garmin in expanding its aviation product offerings.

Portfolio Pulse from Benzinga Newsdesk

September 17, 2024 | 11:16 am