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Saturday, June 13, 2026

Tag: FDA

WuXi Biologics Singapore CRDMO Hub Completes Modular Topping-Out of Drug Product Facility

SINGAPORE, June 4, 2026 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced that it has completed the...

Target Recalls Up & Up Fragrance Free and Fresh Cucumber Scented Baby Wipes Due to Potential Microbial Contamination

MINNEAPOLIS, June 4, 2026 /PRNewswire/ -- Target is voluntarily recalling Up & Up Fragrance Free and Up & Up Fresh Cucumber Scented Baby Wipes...

Laguna Treatment Center Warns of Concerning Increase in Patients Seeking Help for Kratom Addiction

Orange County addiction treatment center sees alarming rise in kratom dependence and warns of the risks.

MAIA Biotechnology Reports Strong Enrollment and Dosing Momentum in Pivotal Phase 3 Non-Small Cell Lung Cancer Trial

MAIA’s novel telomere-targeting therapy being evaluated as a third-line treatment for advanced non-small cell lung cancer

Emergent BioSolutions Supports Victoria’s Voice Foundation’s National Naloxone Awareness Day to Help Save Lives from Opioid Overdose

Efforts focus on increasing awareness, expanding access to lifesaving NARCAN® Nasal Spray and reaching more communities with educational initiatives and resources
Efforts focus on increasing awareness, expanding access to lifesaving NARCAN® Nasal Spray and reaching more communities with educational initiatives and resources

LIGHT AI ANNOUNCES INITIATION OF FDA PIVOTAL CLINICAL TRIAL FOR QUICKSCAN™ STREP A SOFTWARE AS A MEDICAL DEVICE (SaMD)

Ethics Committee Approval Received for Pivotal Study Intended to Support U.S. FDA Class II Submission for QuickScan™ Strep AVANCOUVER, BC, June 4, 2026 /CNW/...

Mammotome Expands Access to Innovative Breast Biopsy Site Marker

Securing this CE mark expands access to the HydroMARK™ Plus markers across Europe, combining proprietary hydrogel technology with features designed to support marker stability...

Celcuity Inc. Announces Pricing of Upsized Public Offering of 0.250% Convertible Senior Notes Due 2032

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced the pricing of its upsized underwritten public offering of $500,000,000 aggregate principal amount of its 0.250% convertible senior notes due 2032 (the “Convertible Notes”). The aggregate principal amount of the offering was increased from the previously announced offering size of $400,000,000.

Persist AI Teams up with Microsize and Micromacinazione (Micmac) to Launch First-of-Its-Kind Early-Stage “Micromill” Formulation Platform, Enabling Drug Development Decision With Milligrams of API

New collaboration delivers a fully integrated formulation workflow from early solubility studies to high-throughput dissolution, stability, and in-process analytics, making drug formulation less artisanal...

Coloplast’s Next Generation Inflatable Penile Prosthesis Approved by the FDA – can help millions of men

The global leader within intimate healthcare today announced FDA approval of Titan Prime, an inflatable penile prosthesis (IPP) that represents the company’s next-generation device and will be available in the U.S. in late 2026. 

MannKind Enters Data-Rich Development Period with Completion of Randomization in Phase 1b INFLO-1 Study and Enrollment of First Patient in Phase 2 INFLO-2 Trial...

MannKind Enters Data-Rich Development Period with Completion of Randomization in Phase 1b INFLO-1 Study and Enrollment of First Patient in Phase 2 INFLO-2

MindMaze Therapeutics Publishes Invitation to the 2026 Annual General Meeting

GENEVA, June 3, 2026 /PRNewswire/ -- MindMaze Therapeutics Holding SA (SIX: MMTX) (MindMaze Therapeutics or the Company), a global leader in scalable precision neurotherapeutics,...

Wegovy® pill launches in the UAE as Novo Nordisk expands global access to obesity care

Novo Nordisk is launching Wegovy® pill in the UAE, the first country outside the US, to make the Wegovy® pill available to people living with obesity

Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study

Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and...

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