Pharmafile Logo
  • - PMLiVE
  • - PMLiVE
  • Diversity, Equity and Inclusion
  • Communiqué 53 Cover Image

safinamide

- PMLiVE

FDA approves pre-filled syringe version of argenx’s immune disorder drug Vyvgart

The authorisation will give patients the flexibility to decide when and where they receive treatment

- PMLiVE

FDA grants interchangeable designation to Celltrion’s Humira biosimilar Yuflyma

The drug is approved for inflammatory conditions such as Crohn's disease and plaque psoriasis

- PMLiVE

BMS receives FDA approval for immunotherapy combination in liver cancer

Around 42,240 people are expected to be diagnosed with liver cancer in the US this year

Bayer symbol

Bayer’s Vitrakvi receives full FDA approval for NTRK gene fusion-positive tumours

The US regulator first approved the TRK inhibitor in 2018 under its accelerated approval pathway

- PMLiVE

BMS granted FDA approval for immunotherapy combination in colorectal cancer

More than 154,000 cases of the disease are expected to be diagnosed in the US this year

- PMLiVE

Amgen’s Uplizna approved by FDA as first treatment for rare disease IgG4-RD

Immunoglobulin G4-related disease affects approximately 20,000 people in the US

- PMLiVE

Organon/Henlius announce EMA validation for Perjeta biosimilar HLX11

The reference medicine holds approvals for multiple HER2-positive breast cancer indications

- PMLiVE

AstraZeneca’s Imfinzi regimen approved by FDA to treat bladder cancer

Around half of patients who undergo bladder removal surgery experience disease recurrence

- PMLiVE

Novartis’ Pluvicto granted FDA approval for expanded prostate cancer use

The authorisation approximately triples the number of patients eligible to receive the therapy

- PMLiVE

FDA approves Exelixis’ Cabometyx to treat advanced neuroendocrine tumours

Approximately 380,000 people in the US were affected by NETs in 2024

- PMLiVE

GSK’s antibiotic Blujepa granted FDA approval to treat urinary tract infections

Blujepa is the first in a new class of oral antibiotics for uncomplicated UTIs in nearly 30 years

- PMLiVE

FDA approves Soleno’s Vykat XR as first treatment for hyperphagia in Prader-Willi syndrome

The rare genetic disorder affects an estimated one in every 15,000 newborns in the US

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links