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GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
GSK today announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA)…
Novartis’ Fabhalta shows significant proteinuria reduction in Phase 3 IgAN trial
Novartis said that Fabhalta (iptacopan) has shown meaningful and statistically significant proteinuria reduction of 38.3% versus placebo as per pre-specified…
FDA approves Basilea’s antibiotic Zevtera for three indications
Basilea Pharmaceutica has received approval from the US Food and Drug Administration (FDA) for Zevtera (ceftobiprole medocaril sodium for injection)…
Genmab to acquire ADC developer ProfoundBio for $1.8bn
Danish drugmaker Genmab has agreed to acquire ProfoundBio, a clinical-stage biotechnology company developing antibody-drug conjugates (ADCs) for certain cancers, for…
Ipsen licenses Sutro Biopharma’s ADC STRO-003 in deal worth up to $900m
French biopharmaceutical company Ipsen has licensed STRO-003, an antibody-drug conjugate (ADC) for solid tumours, from US-based Sutro Biopharma in a…
Eisai submits sBLA to FDA for Leqembi IV maintenance dosing in Alzheimer`s
Eisai has submitted the supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for the use…
FDA approves Akebia Therapeutics’ Vafseo for anaemia caused by CKD
Akebia Therapeutics has received approval from the US Food and Drug Administration (FDA) for Vafseo (vadadustat) tablets to treat anaemia…
Nuvation Bio to acquire oncology firm AnHeart Therapeutics
US-based Nuvation Bio has agreed to acquire AnHeart Therapeutics, an oncology-focused clinical-stage biopharmaceutical firm, in an all-stock transaction. The acquisition…
AbbVie to acquire clinical-stage firm Landos Biopharma for up to $212.5m
AbbVie has agreed to acquire Landos Biopharma, a clinical stage biopharmaceutical company, engaged in developing oral therapies for autoimmune diseases,…
Q32 Bio Announces Closing of Merger with Homology Medicines and Concurrent Private Placement of $42 Million
Q32 Bio, a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced the completion…