FDA Archives - Page 129 of 220

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atai Life Sciences Initiates Phase 2b proof-of-concept trial Of RL-007 For Cognitive Impairment Associated With Schizophrenia

December 19, 7:59 AM

The phase 2b proof-of-concept trial will evaluate the novel compound, RL-007, for pro-cognitive effects in patients with Cognitive Impairment Associated with Schizophrenia (CIAS). The trial was initiated and has begun

ATAI

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Eagle Pharmaceuticals Receives FDA Approval For Additional Indication For PEMFEXY In Combination With Pembrolizumab And Platinum Chemotherapy

By Benzinga Newsdesk

December 19, 7:51 AM

-- Additional indication is for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations -- -- Represents the fifth indication for

EGRX

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Cerevel Reports Results In Emraclidine Ambulatory Blood Pressure Monitoring Trial; Co. Reports ‘Data provide clear evidence that emraclidine does not induce an increase in blood pressure with chronic dosing in people living with schizophrenia’

By Benzinga Newsdesk

December 19, 7:32 AM

Data provide clear evidence that emraclidine does not induce an increase in blood pressure with chronic dosing in people living with schizophrenia Emraclidine demonstrated a mean change from baseline in 24-hour

CERE

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RadNet’s Artificial Intelligence Subsidiary, DeepHealth, Announces FDA Clearance Of Its Third AI Mammography Product

By Benzinga Newsdesk

December 19, 7:08 AM

RadNet, Inc. (NASDAQ:RDNT), today announced that its subsidiary DeepHealth, Inc., a leading developer of artificial intelligence (AI) for mammography interpretation, has received FDA clearance of its mammography density

RDNT

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AstraZeneca Earlier Announced Forxiga Recommended for Approval in the EU by CHMP for Symptomatic Chronic Heart Failure

By Charles Gross

December 19, 6:08 AM

AstraZeneca's Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) to extend the indication for heart failure with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF) including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).

AZN

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AstraZeneca Announced Enhertu Recommended for Approval in the EU by CHMP for Patients with HER2-low Metastatic Breast Cancer

By Charles Gross

December 19, 5:49 AM

AstraZeneca and Daiichi Sankyo's Enhertu is the first HER2-directed therapy to demonstrate a significant survival benefit vs. chemotherapy in this patient population.

AZN

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FDA Green Lights New Study Testing IV Ketamine Infusion For Depressive Disorder

By Lara Goldstein

December 16, 6:03 PM

After a full review of healthcare provider Ehave Inc.'s (OTC Pink: EHVVF) IND application, the U.S.

EHVVF

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FDA
News

UK Health Security Agency Says Nasal Flu Vaccine May Help Reduce Cases Of Group A Strep

By Benzinga Newsdesk

December 16, 11:50 AM

https://www.flumistquadrivalent.com/

AZN

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FDA
News

NeuroSense Therapeutics Says On Dec. 13, 2022 FDA Provided Comment That Data Submitted Do Not Support Entire Paradigm Study Duration, Says Co. Responded To Comment Providing Additional Supportive Data, Justification For Study Duration

By Michael Horton

December 15, 6:30 PM

-SEC Filing

NRSN

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FDA OKs Ketamine For Treating Organ Transplant Injuries With ‘Orphan Drug’ Status

By Lara Goldstein

December 15, 3:12 PM

The U.S. Food and Drug Administration (FDA) has granted PharmaTher Holdings Ltd. (OTCQB: PHRRF) an Orphan Drug designation for ketamine in the prevention of injury from organ transplantation.

PHRRF