BioSpace News Archive

FDA

FDA clears ImageBiopsy Labs’ latest AI-powered Software for a comprehensive Set of Automated Measurements on Long Leg Radiographs

ImageBiopsy Lab announced it has received clearance from the United States Food and Drug Administration (FDA) for IB Lab LAMA , the first fully-automated radiological image processing software for geometric length and angle measurements of the lower limb on full leg X-rays.

June 23, 2023
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2 min read
BioForest

BIOTRONIK Demonstrates Ongoing Commitment to Advancing Scientific Knowledge at HRS

Continuing a history of commitment to furthering research in its field, four studies supported by BIOTRONIK’s real-world evidence generating research initiative, CERTITUDE, were presented at Heart Rhythm 2023 on May 20th and 21st.

June 23, 2023
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3 min read
Jubilant Radiopharma Introduces RUBY Mobile Solutions™

Jubilant DraxImage Inc., dba Jubilant Radiopharma, a wholly-owned subsidiary of Jubilant Pharma Limited, is pleased to announce the clearance by the FDA to use its RUBY Rubidium Elution System™ and RUBY-FILL® in mobile settings.

June 23, 2023
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5 min read
Business

AbbVie Declares Quarterly Dividend 6-22-23

The board of directors of AbbVie Inc. (NYSE: ABBV) today declared a quarterly cash dividend of $1.48 per share.

June 23, 2023
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1 min read
Pharm Country

Cyltezo®, First Interchangeable Biosimilar to Humira®, Receives Preferred Formulary Status with Optum Rx for Commercially Insured Patients

Boehringer Ingelheim today announced that Optum Rx, a pharmacy benefit manager and subsidiary of UnitedHealth Group, will place Cyltezo® (adalimumab-adbm) on its commercial formulary as a preferred brand, which covers more than 66 million members.

June 23, 2023
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12 min read
BioCapital

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders.

June 23, 2023
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3 min read
FDA

The Montreal Heart Institute Welcomes FDA Approval of Colchicine for the Treatment of Cardiovascular Diseases

The Montreal Heart Institute (MHI) welcomes the approval by the United States Food and Drug Administration (FDA) of colchicine for cardiovascular prevention.

June 23, 2023
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2 min read
BioCapital

Kala Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Kala Pharmaceuticals, Inc., announced that the Company granted non-statutory stock options and restricted stock units to new employees as inducement awards outside the Company’s Amended and Restated 2017 Equity Incentive Plan in accordance with Nasdaq Listing Rule 5635.

June 23, 2023
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2 min read
Business

Mirati Therapeutics Appoints Industry Veteran Carol Gallagher, Pharm.D. as New Independent Director

Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced its Board of Directors has appointed a new independent director, Dr. Carol Gallagher.

June 23, 2023
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4 min read
Biotech Beach

Enochian BioSciences Inc. Announces Adjournment of 2023 Annual Stockholder Meeting

Enochian BioSciences Inc. wishes to advise that its 2023 Annual Stockholder Meeting, which was scheduled to be held yesterday, June 22, 2023 at 12:00 p.m. Eastern Time, was convened and adjourned, without any business being conducted, due to the lack of the required quorum.

June 23, 2023
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3 min read