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

suicide prevention drug

- PMLiVE

FDA approves Fujirebio’s Lumipulse as first Alzheimer’s disease blood test

The device offers a less invasive option compared to current PET scans and CSF tests

- PMLiVE

AbbVie’s Emrelis granted FDA accelerated approval to treat advanced lung cancer

An estimated 226,650 people will be diagnosed with lung cancer in the US this year

- PMLiVE

FDA approves Verastem Oncology’s combination therapy for rare ovarian cancer type

Approximately 6,000 to 8,000 women in the US are living with low-grade serous ovarian cancer

- PMLiVE

FDA announces rapid rollout of AI system to accelerate drug review process

The move follows the completion of a new AI-assisted scientific review pilot

- PMLiVE

Johnson & Johnson’s Imaavy granted FDA approval for rare autoimmune disease gMG

Myasthenia gravis affects an estimated 700,000 people worldwide

- PMLiVE

FDA approves Abeona’s epidermolysis bullosa gene therapy Zevaskyn

The sheet-based treatment is expected to be available from the third quarter of this year

- PMLiVE

AbbVie’s JAK inhibitor Rinvoq granted FDA approval to treat giant cell arteritis

The drug could allow patients to taper off steroids and achieve sustained remission

- PMLiVE

Sanofi/Regeneron’s Dupixent granted FDA approval for chronic spontaneous urticaria

More than 300,000 people in the US are living with uncontrolled cases of the inflammatory skin disease

- 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

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links