Pharma Exclusives Pressreleases
GRI Bio Reports Full Year 2024 Financial Results and Reiterates Expected Clinical Data Readouts in 2025 for Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis (“IPF”)
Monday, March 17, 2025GRI Bio Inc a biotechnology company advancing an innovative pipeline of Natural Killer T NKT cell modulators for the treatment of inflammatory fibrotic and autoimmune diseases has reported its financial results for the fiscal year ended December an...
Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients
Tuesday, March 11, 2025Biogen Inc announced the initiation of dosing in the global clinical study TRANSCEND The Phase study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult kidney transplant recipients diagnosed w...
Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial
Tuesday, March 11, 2025Arvinas Inc and Pfizer Inc announced positive topline results from the Phase VERITAC clinical trial NCT evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptorpositive human epidermal growth factor receptor negative...
Eisai Receives Regulatory Review Outcome for Lecanemab as a Treatment for Early Alzheimer’s Disease in Australia
Monday, March 03, 2025Eisai Co Ltd and Biogen Inc announced that the Therapeutic Goods Administration TGA of Australia has confirmed the initial decision to decline the approval of humanized antisoluble aggregated amyloidbeta AB monoclonal antibody lecanemab generic name...
Eton Pharmaceuticals Announces Commercial Launch of Galzin® (zinc acetate) Capsules
Monday, March 03, 2025Eton Pharmaceuticals Inc an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases today announced that it has launched Galzin zinc acetate capsules Galzin is FDAapproved for the maintenance treatment...
AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Giant Cell Arteritis
Friday, February 28, 2025AbbVietoday announced that the European Medicines Agencys Committee for Medicinal Products for Human Use CHMP adopted a positive opinion recommending the approval of upadacitinib RINVOQ mg once daily for the treatment of adult patients
FDA Prioritises Review of Merck’s Application for KEYTRUDA® (pembrolizumab) with Standard Treatment for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma
Tuesday, February 25, 2025Merck NYSE MRK known as MSD outside of the United States and Canada today announced the US Food and Drug Administration FDA has accepted for priority review a new supplemental Biologics License Application sBLA seeking approval for KEYTRUDApembrolizu...
Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft™ Wound Care Products
Tuesday, February 25, 2025Celularity 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, 2025Celularity 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, 2025Gilead 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...
