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Tag: approval

Mission Produce® Announces Fiscal 2026 Second Quarter Financial Results

Acquisition of Calavo Growers completed May 28, 2026

Capricor Therapeutics to Present at Upcoming Investor Conferences

SAN DIEGO, June 08, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that senior management will participate in the following upcoming investor conferences.  

Provectus Biopharmaceuticals Announces Investor Webinar for 2026 Annual Meeting of Stockholders

KNOXVILLE, Tenn., June 08, 2026 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (“Provectus” or the “Company”) (OTCQB: PVCT) today announced that its 2026 annual stockholder meeting (the “Annual Meeting”), including shareholder meeting activities and a company update, will be accessible by Zoom webinar (the “Webinar”). The in-person meeting will be held on Thursday, June 18, 2026 at Perkins Place Office Building, located at 525 Portland Street, Knoxville, Tenn., beginning at 4:00 p.m. Eastern Time.

Helius Minerals Provides Status Update on Serra Pelada Project Acquisition Transaction

VANCOUVER, BC, June 8, 2026 /CNW/ - Helius Minerals Limited ("Helius" or the "Company") (TSXV: HHH) is pleased to provide an update on the status...

Pony AI Inc. Announces Results of the Annual General Meeting

GUANGZHOU, China, June 8, 2026 /PRNewswire/ -- Pony AI Inc. ("Pony.ai" or the "Company") (NASDAQ: PONY; HKEX: 2026), a global leader in achieving large-scale...

Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®

REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration.

Telenor receives approval to acquire GlobalConnect’s consumer business in Norway

The Norwegian Competition Authority has approved Telenor's acquisition of GlobalConnect's Norwegian fibre business for residential customers

Sapu Nano Expands International Development of Sapu003 and Appoints Global Clinical Trials (GCT) as Lead CRO for Phase 1b Program

SAN DIEGO, June 8, 2026 /PRNewswire/ -- Sapu Bioscience LLC announced the expansion of its Phase 1b clinical development program for Sapu003 (Everolimus for...

LENZ Therapeutics Announces Everest Medicines Acquired Rights to Develop and Commercialize VIZZ® (LNZ100) in Greater China

The New Drug Application for LNZ100 in China was submitted September 2025 with approval anticipated in Q1 2027
The New Drug Application for LNZ100 in China was submitted September 2025 with approval anticipated in Q1 2027

AMGEN PRESENTS NEW DATA ACROSS ITS CARDIOMETABOLIC PORTFOLIO AT AMERICAN DIABETES ASSOCIATION 86TH SCIENTIFIC SESSIONS

VESALIUS-CV Subgroup Results Show Repatha® Reduces Risk of First Major Cardiovascular Events by 29% in People Living with High-Risk DiabetesNew Real-World Data Highlight Treatment...

Boehringer Ingelheim’s survodutide Phase III trial showed targeted 34% visceral and 63% liver fat reduction, while minimizing lean mass loss in pre-specified analysis, supporting...

Ingelheim, Germany - Boehringer Ingelheim today announced positive results from two global Phase III trials of its glucagon/GLP-1 dual agonist survodutide (BI 456906), SYNCHRONIZE-1 and SYNCHRONIZE-MASLD.2,4 The results demonstrate survodutide’s potential to reduce weight and therefore improve metabolic health in two distinct populations: adults living with obesity or overweight, without type 2 diabetes (SYNCHRONIZE-1),and adults with overweight or obesity with metabolic dysfunction-associated steatotic liver disease (MASLD) with evidence of inflammation and or fibrosis (SYNCHRONIZE-MASLD).4 Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD were presented today at the American Diabetes Association’s (ADA) 2026 Scientific Sessions and published simultaneously in The New England Journal of Medicine and Nature Medicine respectively.5,6

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