PharmaShots

APRIL 7, 2023

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)

FDA 53

FDA Immunization 53

PharmaShots

JUNE 2, 2023

Impact Therapeutics Entered into a License and Collaboration Agreement with Eikon Therapeutics to Develop and Commercialize IMP1734 Date: June 02, 2023 | Tags: Impact Therapeutics, Eikon Therapeutics, IMP1734, Pharma, China, Hong Kong, Macau, Taiwan BMS’ Mavacamten Receives the NICE Recommendation for the Treatment of Obstructive Hypertrophic (..)

FDA 40

FDA 40

PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

FDA 40

FDA Chemotherapy Immunization Hospitals 40

pharmaphorum

MAY 17, 2021

There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see a sufficient benefit with Alexion’s Soliris (eculizumab) or Ultomiris (ravulizumab), but the regulator opted for a broad indication that included first-line treatment for PNH. billion and $1.1

FDA 52

FDA Labelling Vaccines 52

pharmaphorum

MARCH 23, 2022

Vyvgart (efgartigimod alfa) became the first drug in the FcRn class to be approved by the FDA last December, and despite a $225,000 annual price tag is predicted to make relatively modest sales in its IV version, which will compete with other IV gMG drugs like AstraZeneca/Alexion’s C5 inhibitor Soliris (eculizumab).

FDA 52

FDA 52