Streetbeat News

Regulatory

SPAI

Safe Pro has received a Notice of Allowance from the US Patent and Trademark Office for its AI-powered Spotlightai drone image analysis and reporting software platform, which identifies, locates, and maps explosives.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 11:50 am

APLT

Applied Therapeutics shares rose after the FDA announced that an advisory committee meeting is no longer required for the company.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 11:42 am

OPT

Opthea has completed the Drug Substance Process Performance Qualification (PPQ) campaign for its drug Sozinibercept. This marks a significant milestone in the drug's development process.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 11:34 am

VERO

Venus Concept has received clearance from the Therapeutic Goods Administration in Australia to market its Venus Bliss MAX system.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 11:32 am

APLT

The FDA has informed Applied Therapeutics that an advisory committee meeting is no longer required for their product. This could expedite the approval process, potentially impacting the company's stock positively.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 11:07 am

APLT

Applied Therapeutics provided an update on the New Drug Application (NDA) review for Govorestat, a treatment for Classic Galactosemia. This update is crucial for the company's future prospects and investor interest.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 11:04 am

GSK

GSK's Phase 3 trial of Arexvy, an RSV vaccine, co-administered with Shingrix, a shingles vaccine, met its primary endpoint in adults 50 and older. The vaccines were well tolerated, showing acceptable safety profiles, advancing the science of co-administration of adult vaccines.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 11:04 am

VVOS

Vivos Therapeutics has received FDA 510(k) clearance for its DNA appliance to treat moderate to severe pediatric sleep apnea and snoring in children aged 6 to 17. This approval could enhance Vivos' market position in pediatric sleep disorder treatments.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 11:02 am

GOOG

GOOGL

Google, a subsidiary of Alphabet Inc., won an appeal against a $1.66 billion EU antitrust fine related to its online search advertising practices. The General Court annulled the fine, citing the European Commission's failure to consider all relevant circumstances. Despite this, the court upheld most of the Commission's assessments regarding Google's antitrust practices.

Portfolio Pulse from Rounak Jain

September 18, 2024 | 10:59 am

MRK

The FDA has approved Merck's Keytruda in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma.

Portfolio Pulse from Benzinga Newsdesk

September 18, 2024 | 10:47 am