FDA Archives - Page 197 of 220

1 minute read

RedHill Biopharma Announces EU Orphan Drug Designation For RHB-204 For NTM Infections

August 17, 8:02 AM

Developed as the first stand-alone standard of care first-line therapy for NTM disease caused by Mycobacterium avium complex (MAC) infection, RHB-204 is currently undergoing a Phase 3 study in the U.S. EMA Orphan Drug

RDHL

2 minute read

Arrowhead Files For Regulatory Clearance To Initiate Phase 1/2a Study Of ARO-MMP7 For Idiopathic Pulmonary Fibrosis

By Benzinga Newsdesk

August 17, 7:35 AM

Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-MMP7, the company's investigational RNA interference (RNAi)

ARWR

2 minute read

FDA
News

GSK Announced FDA Accepted New Drug Application for Momelotinib for the Treatment of Myelofibrosis

By Charles Gross

August 17, 6:15 AM

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for momelotinib, a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anaemia. The US FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.

GSK

2 minute read

Recap Of Tuesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

August 16, 5:54 PM

The U.S. Food and Drug Administration (FDA) has approved Amphastar’s (NASDAQ:AMPH) New Drug Application (ND”) for Epinephrine injection…

AMPH

1 minute read

Roche’s Polivy Combo Regime Under FDA Review For Type Of Blood Cancer

By Vandana Singh

August 16, 2:59 PM

Roche Holdings AG (OTC:RHHBY) announced that the FDA accepted its supplemental marketing application for Polivy. Polivy is being developed by Roche…

RHHBF

1 minute read

‘COVID public health emergency appears to be headed for extension’ -Axios Report

By Benzinga Newsdesk

August 16, 1:35 PM

https://www.axios.com/2022/08/16/covid-public-health-emergency-extension?utm_campaign=editorial&utm_source=twitter&utm_medium=social

SPY

1 minute read

FDA
News

Precipio Launches New 1-Step Technology For All HemeScreen Assays

By Benzinga Newsdesk

August 16, 11:05 AM

Specialty cancer diagnostics company Precipio, Inc. (NASDAQ:PRPO), announces the launch of its second generation of HemeScreen panels. Precipio's customers using HemeScreen in their laboratory will have the

PRPO

1 minute read

FDA
News

Neurosense Therapeutics Reports Strong Patient Enrollment In Phase IIb Paradigm Trial For PrimeC For Treatment Of ALS

By Benzinga Newsdesk

August 16, 9:30 AM

-SEC Filing

NRSN

1 minute read

Sorrento’s Scilex Holding Announces Expanding Coverage

By Benzinga Newsdesk

August 16, 9:01 AM

30 million lives now covered by one of the largest national PBMs Continue to work with this PBM to access an additional 20 million lives The team continues to work with the national PBM's and health plans to

SRNE

1 minute read

FDA
News

HeartBeam Announces FDA Submission Of HeartBeam AIMI Product

By Benzinga Newsdesk

August 16, 8:42 AM

Submission Seeks Approval for the Company's Proprietary ECG Technology to Aid in Diagnosis of Heart Attack in $500 million Total Addressable Market 18+ million People in the US have Coronary Artery DiseaseSubmission Seeks Approval for the Company's Proprietary ECG Technology to Aid in Diagnosis of Heart Attack in $500 million Total Addressable Market

BEAT