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Tag: U.S. Food and Drug Administration

The Scientific Advisory Group (SAG) to Convene to Discuss the Marketing Authorization Application for lecanemab in the EU

ACN Newswire
TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the...

Avanos Medical, Inc. Reports Preliminary Fourth Quarter and Full-Year 2023 Financial Results; Revises Preliminary 2024 Revenue Outlook | BioSpace

Medical Devices
ALPHARETTA, Ga., Jan. 4, 2024 /PRNewswire/ -- Avanos Medical, Inc. (NYSE: AVNS) today reported selected, unaudited preliminary financial results for the fourth quarter and...

Will This Be Our Year?

Cannabis
In 1919, a ban on alcohol exposed a cultural divide between urban and rural America and led to a spike in organized crime. Federal,...

Kleinfeld Kaplan & Becker LLP Announces Election of Samantha N. Hong as Partner – Medical Marijuana Program Connection

Cannabis
WASHINGTON–(BUSINESS WIRE)–Kleinfeld Kaplan & Becker LLP (KKB) is pleased to announce that Samantha N. Hong has been elected to the partnership effective January 1,...

ABK Biomedical announces that its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) | BioSpace

Medical Devices
HALIFAX, NS, Dec. 5, 2023 /PRNewswire/ - ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced...

RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva® Allograft Dermis in Breast Reconstruction | BioSpace

Medical Devices
ALACHUA, Fla., Nov. 27, 2023 /PRNewswire/ -- RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA)...

True or False, Moving Cannabis to a Schedule 3 Drug Means Sending Weed Through the Mail, UPS, or Fed Ex Is Now Legal?

Cannabis
Certain cannabis industry leaders are optimistic that the federal government's reclassification of marijuana from Schedule 1 to Schedule 3 of the Controlled Substances Act...

Zymo Research Receives 510(k) Clearance for its Saliva Self-Collection & Transport Device | BioSpace

Medical Devices
IRVINE, Calif., Nov. 15, 2023 /PRNewswire/ -- Zymo Research announced today that the U.S. Food and Drug Administration (FDA) has cleared its DNA/RNA Shield™ SafeCollect™...

Telix and Mauna Kea Technologies to Expand Collaboration in Urologic Oncology Surgery | BioSpace

Medical Devices
MELBOURNE, Australia and PARIS, Nov. 13, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and Paris-based Mauna Kea Technologies (Euronext Growth:...

BD Advances “One-Stick Hospital Stay” Vision with Launch of Next-Generation Needle-Free Blood Draw Technology | BioSpace

Medical Devices
New Peripheral Line Draw Solution Delivers First and Only Compatibility with Integrated Catheters, Bringing Elevated Standard of Care to More U.S. Hospitals FRANKLIN LAKES,...

FDA Issues Approvable Letter for SeaStar Medical’s Selective Cytopheretic Device for Pediatric Patients | BioSpace

Medical Devices
DENVER, Oct. 30, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences...

Big pharma monopolies: major antitrust cases over the past decade

Biotechnology
Antitrust laws are put in place to prevent unlawful activities like price fixing, as well as monopolies from forming, typically tied to big pharma....
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