Pharma Exclusives Pressreleases

FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease

Wednesday, July 09, 2025

Eli Lilly and Company announced today that the US Food and Drug Administration FDA has approved a label update with a new recommended titration dosing schedule for Kisunla donanemabazbt

Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution)

Tuesday, July 08, 2025

Eton Pharmaceuticals Inc an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases today announced the Companys New Drug Application NDA for ET a proprietary patented

Orchard Therapeutics Announces Last Patient Treated in Registrational Trial of OTL-203 for MPS-I Hurler Syndrome

Monday, July 07, 2025

Orchard Therapeutics a Kyowa Kirin company today announced the last patient has been treated in a registrational trial evaluating the efficacy and safety of OTL an investigational hematopoietic

Moderna Announces Positive Phase 3 Results for Seasonal Influenza Vaccine

Monday, June 30, 2025

Moderna Inctoday announced positive results from a Phase efficacy study P evaluating the relative vaccine efficacy rVE against influenza illness of mRNA the Companys seasonal influenza flu vaccine candidate

Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Primary Membranous Nephropathy

Monday, June 30, 2025

Biogen Inc announced the initiation of dosing in the global clinical study PROMINENT The Phase study will evaluate the efficacy and safety of the investigational drug felzartamab compared to tacrolimus in adults diagnosed with primary

Revolution Medicines and Summit Therapeutics Enter into Clinical Collaboration to Evaluate Combinations of Three RAS(ON) Inhibitors with Ivonescimab in RAS Mutant Tumors

Monday, June 30, 2025

Revolution Medicines Inc a latestage clinical oncology company developing targeted therapies for patients with RASaddicted cancers and Summit Therapeutics Inc Nasdaq SMMT a biopharmaceutical oncology company

AbbVie to Acquire Capstan Therapeutics, Further Strengthening Commitment to Transforming Patient Care in Immunology

Monday, June 30, 2025

AbbVieand Capstan Therapeutics Inc a clinicalstage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using tLNPs today announced a definitive agreement under which AbbVie will acquire Capstan

U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels

Friday, June 27, 2025

Bristol Myers Squibbtoday announced that the US Food and Drug Administration FDA has approved label updates for both of its CAR T cell therapies Breyanzi lisocabtagene maraleucel lisocel for the treatment of large

Gilead Sciences and Kymera Therapeutics Enter Into Exclusive Option and License Agreement to Develop Novel Oral Molecular Glue CDK2 Degraders

Wednesday, June 25, 2025

Gilead Sciences Incand Kymera Therapeutics Inc NASDAQ KYMR today announced that they have entered into an exclusive option and license agreement to accelerate the development and commercialization

Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

Tuesday, June 24, 2025

Datroway has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFRmutated nonsmall cell lung cancer NSCLC who have received prior EGFRdirected therapy and platinumbased chemotherapy