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Regulatory

NNE

NANO Nuclear has filed provisional patents for its Annular Linear Induction Pump technology, which is crucial for its 'ODIN' microreactor and other advanced nuclear reactors. The company aims to secure intellectual property rights with the USPTO.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:33 pm

ARQT

Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) has submitted a supplemental New Drug Application (sNDA) to the FDA for ZORYVE foam, aimed at treating scalp and body psoriasis in individuals aged 12 and over. Clinical trials showed significant improvement and rapid itch reduction, with a favorable safety profile.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:17 pm

BCAB

BioAtla, Inc. (NASDAQ:BCAB) has received FDA Fast Track Designation for its drug ozuriftamab vedotin, aimed at treating recurrent or metastatic squamous cell carcinoma of the head and neck. The drug has shown promising results in Phase 2 trials and the company plans to meet with the FDA for further guidance in the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:16 pm

MLSS

Milestone Scientific announced a new price assignment for its products in two Medicare regions: Jurisdiction L (JL) and Jurisdiction H (JH).

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:15 pm

MLSS

Milestone Scientific has announced that Medicare has assigned a price for its CompuFlo Epidural System in several states and the District of Columbia. This development could potentially increase the adoption and sales of the system.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:15 pm

MLSS

Milestone Scientific Inc (NYSE:MLSS) announced that Novitas Solutions, Inc. has granted a Medicare Part B Physician payment rate for the CompuFlo Epidural System in additional US states. This decision covers two Medicare regions, Jurisdiction L and Jurisdiction H, and follows a similar assignment in Florida. The new pricing assignment is expected to significantly impact the market for the CompuFlo technology, which is designed to improve the accuracy and reduce the discomfort of epidural procedures.

Portfolio Pulse from Vandana Singh

July 23, 2024 | 12:15 pm

ZIMV

ZimVie shares are trading higher following the announcement of FDA clearance and the U.S. launch of GenTek Restorative Components.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:14 pm

ZIMV

ZimVie Inc. (NASDAQ:ZIMV) has announced the U.S. launch of its GenTek® Genuine Restorative Components product portfolio following FDA 510(k) clearance. This launch expands ZimVie's prosthetic offerings, building on the success of the GenTek portfolio in Europe since 2019.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:13 pm

AZTR

Azitra, Inc. (NYSE:AZTR) has strengthened its global intellectual property portfolio with newly granted and allowed patents in the U.S., China, and Canada. These patents protect a filaggrin-secreting strain of Staphylococcus epidermidis for the treatment of atopic dermatitis and other skin diseases. This development broadens Azitra's IP position for its precision dermatology platform.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:12 pm

GH

Guardant Health has launched an enhanced version of its Guardant360 test on the Guardant Infinity platform. The new test covers 10 times more genes and quantifies tumor burden with 10 times higher sensitivity. Medicare and major private payers cover the test for comprehensive genomic profiling of advanced solid tumors.

Portfolio Pulse from Benzinga Newsdesk

July 23, 2024 | 12:09 pm