#FDA

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Implantica Advances US Launch as Leading Surgeons Begin RefluxStop Training

October 27, 2026 (14 days ago)

Implantica accelerates its US market entry as prominent surgeons begin training on the RefluxStop device, aiming to treat millions of patients suffering…

IMP

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Labcorp Deploys BD Onclarity HPV Assay to Expand Diagnostic Screening Access

October 23, 2026 (18 days ago)

Labcorp expands its diagnostic portfolio by adopting the BD Onclarity HPV Assay, enabling flexible screening options including at-home testing for patients across…

LH BDX

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Fresenius Medical Care Gains FDA Clearance for multiFiltratePRO System

October 22, 2026 (20 days ago)

Fresenius Medical Care receives FDA approval for the multiFiltratePRO system, expanding its footprint in the U.S. continuous kidney replacement therapy market with…

FMS

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Sernova and Seraxis Appoint Former FDA Official Dr. Beaston as CMO

October 19, 2026 (22 days ago)

The appointment of Dr. Beaston, a veteran FDA official, bolsters the regulatory and clinical strategy for Sernova and Seraxis as they integrate…

SVA.TO Seraxis BetaNova

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Legacy Healthcare Secures FDA Breakthrough Designation for CINAINU Alopecia Drug

October 13, 2026 (28 days ago)

Legacy Healthcare gains FDA Breakthrough Therapy status for its CINAINU alopecia treatment, marking a critical regulatory advancement for the Swiss biopharmaceutical firm's…

Legacy Healthcare

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FDA Approves New PREVICOX Tablet Formulation for Boehringer Ingelheim

October 7, 2026 (34 days ago)

Boehringer Ingelheim gains FDA clearance for an improved PREVICOX tablet, offering enhanced dosing flexibility and sustainability benefits for the animal health sector.

Boehringer Ingelheim

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Solius Labs Gains Industry Recognition for FDA-Cleared UVB Therapy Device

October 7, 2026 (34 days ago)

Solius Labs earns industry accolades for its FDA-cleared Solius Pro, marking a significant advancement in personalized UVB light therapy technology for the…

Solius Labs

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FDA Approves OMLYCLO as First Interchangeable Biosimilar to XOLAIR

October 5, 2026 (36 days ago)

OMLYCLO secures FDA approval as the first interchangeable biosimilar to XOLAIR, set to be available in multiple dosage strengths to challenge existing…

GSK MRK

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Eli Lilly Gains FDA Approval for Jaypirca to Treat CLL and SLL Patients

October 2, 2026 (39 days ago)

Eli Lilly expands its oncology footprint as the FDA approves Jaypirca for the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma,…

LLY

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Neogen Shares Slide 7.22% Following FDA Action on HYCOAT Product Recall

October 1, 2026 (40 days ago)

Neogen Corporation stock fell 7.22% on Tuesday following FDA regulatory action concerning the recall of its HYCOAT equine product, sparking a new…

NEOG

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Kodiak Sciences Zenkuda Hits Primary Endpoint in Wet AMD Study

September 28, 2026 (43 days ago)

Kodiak Sciences shares rally as Zenkuda demonstrates clinical efficacy in wet AMD, establishing a potential new standard of care with durable 24-week…

KOD

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FDA Approves Eli Lilly's Olumiant for Pediatric Alopecia Areata Treatment

September 25, 2026 (46 days ago)

Eli Lilly secures FDA approval for Olumiant in pediatric alopecia areata, marking a key label expansion following successful Phase 3 clinical trial…

LLY

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