BioPharmSignal logoBioPharmSignal

Biotech News

MIMEDX Announces Favorable Federal Court Ruling in AXIOFILL® Regulatory Classification Matter

MiMedx (MDXG)MiMedxFDA / regulatory

Court Vacates FDA Determinations That AXIOFILL Is Not Minimally Manipulated and Should Be Classified as a Biological Product Order Further Holds That Minimal-Manipulation Analysis Must Consider Tissue Characteristics Relevant to Reconstruction, Repair or Replacement in the Recipient MARIETTA, Ga.,

Related news

MDXGMiMedx2026-04-22 12:00 EST

MIMEDX to Host First Quarter 2026 Operating and Financial Results Conference Call on April 29

MDXGMiMedx2026-03-23 12:00 EST

MIMEDX Announces Launch of CHORIOFIX™

ALVOAlvotech2026-10-05 08:00 EST

FDA approves additional U.S. manufacturing capacity for SIMLANDI®, Alvotech’s biosimilar to Humira®

RHHBYRoche Holdings AG2026-09-30 05:00 EST

Roche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosis

PHARPharming Group2026-09-11 18:00 EST

FDA approves Pharming’s Joenja® as first treatment for children with APDS in the U.S.

RHHBYRoche Holdings AG2026-09-10 05:00 EST

U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments

ALVOAlvotech2026-08-31 08:30 EST

Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations

PHARPharming Group2026-06-04 05:00 EST

Pharming announces U.S. FDA acceptance of sNDA resubmission for Joenja® (leniolisib) to treat children aged 4 to 11 years with APDS

ADMAADMA Biologics2026-05-04 11:00 EST

ADMA Biologics Announces FDA Approval to Expand the Label for ASCENIV™ to Include Pediatric Immune Compromised Patients Two Years of Age and Older

ENTXEntera Bio2026-06-22 12:30 EST

Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis

View all latest news

MiMedx

Placental Tissue Products MIMEDX develops and commercializes placental-tissue products for wound care, burns and surgery. Its processing and product portfolio are designed to provide extracellular-matrix and biologic materials that support healing and tissue repair. Wound-Care Portfolio The company has more than a decade of experience...

Recent company news

MDXGMiMedx2026-09-23 20:01 EST

MIMEDX Announces Favorable Federal Court Ruling in AXIOFILL® Regulatory Classification Matter

MDXGMiMedx2026-09-08 12:00 EST

MIMEDX to Participate in Upcoming Investor Conferences

MDXGMiMedx2026-07-29 20:07 EST

MIMEDX Announces Second Quarter 2026 Operating & Financial Results

MDXGMiMedx2026-07-29 20:01 EST

MIMEDX to Acquire Sanara MedTech

MDXGMiMedx2026-07-20 12:00 EST

MIMEDX to Host Second Quarter 2026 Operating and Financial Results Conference Call on July 29

Stock data

Close
4.64 USD
Market cap
531.74M USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States