FDA - Spark Newswire

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FDA
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Arrowhead Pharma Reports Pauses Its ARO-ENaC Phase 1/2 Trial

Today, 7:34 PM

Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today notified regulatory agencies, institutional review boards, and investigators that effective immediately it is voluntarily pausing AROENaC1001, a Phase 1/2 clinical study

ARWR

5 minute read

Attention Biotech Investors: Mark Your Calendar For July PDUFA Dates

By Shanthi Rexaline

Today, 7:34 PM

June was a month of plenty and also turned out to be a fruitful one from the perspective of Food and Drug Administration approvals. Regulatory reviews mostly produced positive verdicts, and rejections or no-decisions were few and far between.

ALBO

2 minute read

FDA
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UPDATE: Merck Says Decision To Withdraw KEYTRUDA Was Made In Consultation With FDA Following April 29 Oncologic Drugs Advisory Committee Evaluation Of 3rd-Line Gastric Cancer Indication For KEYTRUDA

By Benzinga Newsdesk

Today, 7:34 PM

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company plans to voluntarily withdraw the U.S. accelerated approval indication for KEYTRUDA for the treatment of patients with

MRK

1 minute read

VBI Vaccines Reports New CPT Code Issued For 3-Antigen Prophylactic Hepatitis B Vaccine

By Bill Haddad

Today, 7:34 PM

VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today reported that the American Medical Association (AMA) Current

VBIV

2 minute read

FDA
News

Merck Says Plans To Voluntarily Withdraw U.S. Accelerated Approval Indication For KEYTRUDA

By Benzinga Newsdesk

Today, 7:34 PM

MRK

1 minute read

Concert Pharma Sees US Application Submission For Patchy Hair Loss Candidate In 2023

By Vandana Singh

Today, 7:34 PM

Concert Pharmaceuticals Inc (NASDAQ:CNCE) has announced updated data from its ongoing open-label, long-term extension study of CTP-543 in patients with moderate…

CNCE

1 minute read

Aileron Launches Early-Stage Study For Chemoprotective Candidate In Lung Cancer Settings

By Vandana Singh

Today, 7:34 PM

Aileron Therapeutics Inc (NASDAQ:ALRN) has initiated Phase 1b trial of ALRN-6924 as a chemoprotective agent to treat patients with non-small cell…

ALRN

1 minute read

Alzamend Neuro Submits IND Application For Alzheimer’s-Related Dementia Candidate

By Vandana Singh

Today, 7:34 PM

Ault Global Holdings Inc (NYSE:DPW), a diversified holding company, has announced that Alzamend Neuro Inc (NASDAQ:ALZN) has submitted an investigational new drug…

ALZN

1 minute read

Arcutis Stops ARQ-252 Vitiligo Trial After Formulation-Related Observations In Chronic Hand Eczema Study

By Vandana Singh

Today, 7:34 PM

Arcutis Biotherapeutics Inc (NASDAQ:ARQT) will terminate the Phase 2a trial evaluating ARQ-252 as a potential treatment for vitiligo. The study was initiated…

ARQT