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

Kadmon Holdings

- 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

Sanofi’s tolebrutinib shown to delay MS disability progression in phase 3 study

The BTK inhibitor has been granted FDA priority review to treat the neurodegenerative disease

- 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

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

Sanofi’s Qfitlia granted FDA approval to treat haemophilia A or B

Qfitlia is now the first therapy in the US to treat the rare bleeding disorder regardless of inhibitor status

- 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

- PMLiVE

Sanofi’s investigational MS treatment tolebrutinib granted FDA priority review

Approximately 2.9 million people worldwide are living with the neurodegenerative disease

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links