Streetbeat News

Regulatory

CMND

Clearmind Medicine has received Institutional Review Board approval for its FDA clinical trial of CMND-100 at a second clinical site, focusing on treating alcohol use disorder.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2024 | 12:12 pm

JNJ

Johnson & Johnson announced that its drug TREMFYA® has shown significant results in treating Crohn's disease and ulcerative colitis, achieving high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients. TREMFYA® is FDA-approved for ulcerative colitis and under review for Crohn's disease.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2024 | 12:08 pm

MOVE

Movano Health has provided an update on the FDA review of its EvieMED Ring, stating that it has received additional questions in the final phase of its 510(k) application. The company remains optimistic about obtaining clearance after addressing initial wellness features.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2024 | 12:03 pm

RNG

RingCentral Inc. has received a PAN-India license to offer fully compliant UCaaS and CCaaS solutions, enabling seamless communication for multinational organizations in India. This positions RingCentral as a leader in AI-powered business communications.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2024 | 12:03 pm

AKBA

Akebia Therapeutics announced that its drug Vafseo has been approved for the Transitional Drug Add-On Payment Adjustment by CMS, starting January 1, 2025. This will provide two years of additional reimbursement for dialysis organizations.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2024 | 12:02 pm

FHTX

Foghorn Therapeutics has initiated a Phase 1 trial for its drug FHD-909, targeting SMARCA4 (BRG1) mutated cancers, with a focus on non-small cell lung cancer. This marks a significant step in their clinical development pipeline.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2024 | 11:19 am

MDWD

Mediwound is set to begin a controlled, multicenter Phase 2 study for EscharEx against collagenase ointment for venous leg ulcers in 2025. This study will run concurrently with their ongoing Phase 3 trial.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2024 | 11:18 am

RNAZ

Transcode Therapeutics has successfully dosed all patients in the first cohort of its Phase 1A clinical trial for TTX-MC138, targeting microRNA-10b in metastatic cancer. No significant safety issues have been reported.

Portfolio Pulse from Benzinga Newsdesk

October 10, 2024 | 11:16 am