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Pharma Exclusives Pressreleases

Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft™ Wound Care Products

Tuesday, February 25, 2025

Celularity Inc a regenerative and cellular medicine company today announced that on December it received recommendation letters from the US Food and Drug Administration or FDA Tissue Reference Group or TRG in response to the Companys requests regar...

Celularity Enters Strategic Collaboration Agreement with Clinical Stage Cell Therapy Company

Monday, February 24, 2025

Celularity Inc a cellular and regenerative medicine company today announced that it has entered into a Master Services Collaboration Agreement with BlueSphere Bio Inc BSB covering manufacturing activities for certain BSB cell therapy products

Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis

Friday, February 21, 2025

Gilead Sciences Inc today announced that the European Commission EC has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis PBC in combination with ursodeoxycholic acid UDCA in adults who have a...

Teva and Alvotech Announce SELARSDI™ (ustekinumab-aekn) Injection Now Available in the U.S.

Friday, February 21, 2025

Teva Pharmaceuticals a US affiliate of Teva Pharmaceutical Industries Ltd NYSE and TASE TEVA and Alvotech NASDAQ ALVO today announced the availability of SELARSDI ustekinumabaekn injection in the US a biosimilar to Stelara ustekinumab for the treatme...

Biogen and Stoke Therapeutics Partner to Develop and Market Zorevunersen for Dravet Syndrome Treatment

Wednesday, February 19, 2025

Biogen Incand Stoke Therapeutics Inctoday announced a collaboration for the development and commercialization of zorevunersen a potential firstinclass disease modifying medicine in development for the treatment of Dravet syndrome in all territories o...

U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review

Wednesday, February 19, 2025

Gilead Sciences Inc today announced that the US Food and Drug Administration FDA has accepted its New Drug Application NDA submissions for lenacapavirthe companys twiceyearly injectable HIV capsid inhibitorfor the prevention of HIV as preexposure pro...

WELIREG® (belzutifan) Receives First European Commission Approval for Two Indications

Tuesday, February 18, 2025

Merck known as MSD outside of the United States and Canada today announced that the European Commission EC has conditionally approved WELIREG Mercks oral hypoxiainducible factor alpha

Bio-Techne Announces Release of GMP TcBuster Non-Viral Genome Engineering System

Tuesday, February 18, 2025

BioTechne Corporation a leading provider of innovative life science research tools is pleased to announce the official release of GMP Transposase mRNA for the TcBuster nonviral genome engineering system supporting the development and manufacture of i...

Published Data in The Lancet Diabetes & Endocrinology Highlights Unique Efficacy Benefits of Sotagliflozin to Reduce Major Adverse Cardiovascular Events (MACE)

Tuesday, February 18, 2025

Lexicon Pharmaceuticals Inc today announced The Lancet Diabetes Endocrinology has published a research paper analyzing the ability of sotagliflozin a dual SGLT and SGLT inhibitor to reduce the risks of lifethreatening cardiovascular outcomes

Thermo Fisher Scientific’s New Spatial Imaging System Enables Researchers to Generate High-quality Data, Making it Easier to Enter the Field of Spatial Tissue Proteomics

Thursday, February 13, 2025

Thermo Fisher Scientific Inc the world leader in serving science today introduced the Invitrogen EVOS S Spatial Imaging System This advanced system addresses the limitations of current fluorescent microscopy technologies by enabling researchers to ge...