The Pharma Letter11h
March 2025 EMA/CHMP meeting new drug opinions
The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three ...
MPR13h
FDA Expands Approval of Pluvicto in PSMA-Positive Metastatic CRPC
The Food and Drug Administration (FDA) has expanded the approval of Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) to include patients with ...
European committee says Lilly Alzheimer's drug shouldn't get marketing approval
A European regulatory committee has rejected Eli Lilly's U.S.-approved Alzheimer's disease treatment over potentially ...
CHMP Recommends Against Approval of Eli Lilly's Kisunla Alzheimer's Drug — Update
Eli Lilly, which is seeking European approval of Kisunla for the treatment of early symptomatic Alzheimer's, said it will seek re-examination by CHMP. The Indianapolis drugmaker said it remains ...
precisionmedicineonline16h
EMA's CHMP Recommends Against Approval of Eli Lilly's Alzheimer's Drug Kisunla in Europe
Lilly in a statement Friday said it will ask the CHMP to reexamine its opinion. Given the drug's approval by regulators in other countries, "Lilly remains confident in the safety and effectiveness of ...
Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications
Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications ...
EU regulator rejects Eli Lilly's Alzheimer's drug
The European Union's drugs regulator on Friday rejected Eli Lilly's Alzheimer's drug, saying the treatment's small impact on ...
TREMFYA® (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease
Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease 1,2,3 Beerse, Belgium (28 March 2025) – Johnson & Johnson today announced that the ...