Streetbeat News

Regulatory

APLT

Applied Therapeutics' stock is trading lower following the FDA's decision to extend the review period for the NDA of govorestat, aimed at treating Classic Galactosemia, by three months.

Portfolio Pulse from Benzinga Newsdesk

April 01, 2024 | 11:38 am

BAX

Baxter International Inc. (NYSE:BAX) has received U.S. FDA 510(k) clearance for its Novum IQ large volume infusion pump (LVP) with Dose IQ Safety Software, expanding its Novum IQ Infusion Platform. This approval enhances Baxter's infusion therapy offerings by allowing clinicians to use a unified system across different patient care settings, showcasing Baxter's ongoing innovation in the field.

Portfolio Pulse from Benzinga Newsdesk

April 01, 2024 | 11:16 am

VTRS

Viatris has launched Ryzumvi, the only FDA-approved eye drop in the U.S. for reversing pharmacologically-induced mydriasis (eye dilation). This marks a significant milestone as Ryzumvi becomes the sole product available commercially for this purpose.

Portfolio Pulse from Benzinga Newsdesk

April 01, 2024 | 11:00 am

AMZN

CRM

FTEC

MSFT

XLK

Microsoft Corp has decided to sell its Teams application separately from its Office suite globally to address antitrust concerns, following a similar move in Europe six months earlier. This decision comes after an investigation by the European Commission, triggered by a complaint from Slack, owned by Salesforce Inc. Despite these changes, Microsoft may still face EU antitrust charges related to pricing and interoperability issues. Microsoft is also engaging with CISPE, including Amazon.Com Inc, to address a complaint about its cloud computing licensing practices. The stock has gained over 46% in the last 12 months, with exposure available through SPDR Select Sector Fund – Technology and Fidelity MSCI Information Technology Index ETF.

Portfolio Pulse from Anusuya Lahiri

April 01, 2024 | 10:17 am

GUTS

Fractyl Health's stock price increased following the FDA's IDE approval for its Revita Remain-1 study, aimed at treating obesity in patients who have stopped responding to GLP-1 based drugs.

Portfolio Pulse from Benzinga Newsdesk

April 01, 2024 | 10:15 am

LQDA

UTHR

Judge Andrews has set aside the injunction issued in August 2022 against Liquidia, allowing the FDA to proceed with the final approval of Liquidia's new drug application for Yutrepia (Treprostinil) Inhalation Powder. The injunction was initially in place due to a lawsuit filed by United Therapeutics.

Portfolio Pulse from Benzinga Newsdesk

April 01, 2024 | 10:09 am

GUTS

The FDA has approved Fractyl Health's Investigational Device Exemption for a study on Revita's efficacy in maintaining weight loss after stopping GLP-1 receptor agonist treatment. This marks a significant step for Fractyl Health in exploring innovative treatments for weight management.

Portfolio Pulse from Benzinga Newsdesk

April 01, 2024 | 10:02 am

APLT

BTBT

CIFR

CLSK

DJT

MSTR

OCGN

OXM

Oxford Industries reported disappointing Q4 results and weak Q1 guidance, causing its shares to drop 6% in pre-market trading. Other stocks like Applied Therapeutics, CleanSpark, Trump Media & Technology Group, Ocugen, MicroStrategy, Bit Digital, Toyota Motor, and Cipher Mining also saw pre-market declines due to various factors including FDA review extensions, analyst ratings, and sales performance.

Portfolio Pulse from Avi Kapoor

April 01, 2024 | 9:13 am

AZN

The FDA has approved AstraZeneca's Voydeya (Danicopan) as an add-on therapy to Ravulizumab or Eculizumab for treating extravascular hemolysis in adults with Paroxysmal Nocturnal Hemoglobinuria.

Portfolio Pulse from Benzinga Newsdesk

April 01, 2024 | 8:15 am

USDTUSD

Andrey Zverev, a Russian middleman, has been using Tether (USDT) to facilitate transactions for Russian companies to procure high-tech equipment and weapons parts, bypassing Western sanctions. The U.S. Treasury Department is seeking legislation to block transactions in U.S. dollar-denominated stablecoins like Tether in response to their use in evading sanctions.

Portfolio Pulse from Benzinga Neuro

April 01, 2024 | 6:58 am