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

Pradaxa

- PMLiVE

FDA grants fast track designation to Nektar’s rezpegaldesleukin in alopecia areata

Approximately 700,000 people in the US currently have some form of the autoimmune disease

- PMLiVE

AstraZeneca’s Imfinzi granted FDA priority review to treat early-stage gastric cancer

Gastric cancer is the fifth leading cause of cancer-related deaths globally

- PMLiVE

LEO’s Anzupgo granted FDA approval to treat moderate-to-severe chronic hand eczema

The cream is now the first treatment approved by the regulator specifically for this patient population

- PMLiVE

FDA appoints George Tidmarsh as director of CDER

Tidmarsh has most recently been serving as adjunct professor of paediatrics and neonatology at Stanford University

- PMLiVE

LEO Pharma gains access to Boehringer’s skin disease drug for €90m upfront

Spevigo is already approved in over 40 countries to treat generalised pustular psoriasis

- PMLiVE

Johnson & Johnson’s TAR-200 granted FDA priority review to treat bladder cancer

An estimated 84,870 people will be diagnosed with bladder cancer in the US this year

Bayer symbol

Bayer’s Kerendia granted FDA approval for new heart failure indication

Approximately 55% of the 6.7 million adults in the US with HF have an LVEF of at least 40%

- PMLiVE

FDA publishes over 200 complete response letters in effort to increase transparency

The letters were issued in response to applications submitted to the regulator between 2020 and 2024

- PMLiVE

FDA approves Dizal’s oral therapy Zegfrovy to treat advanced lung cancer

Around 226,650 new cases of lung cancer are expected to be diagnosed in the US this year

regeneron headquarters

Regeneron’s Lynozyfic granted FDA accelerated approval to treat multiple myeloma

More than 36,000 new cases of the blood cancer are expected to be diagnosed in the US this year

- PMLiVE

FDA approves Sobi’s Gamifant to treat severe inflammatory arthritis complication

The drug is now the first-ever therapy approved in the US to treat MAS in patients with Still's disease

- PMLiVE

Sanofi/Regeneron’s Dupixent granted FDA approval for bullous pemphigoid

Around 27,000 adults in the US are living with uncontrolled cases of the chronic skin disease

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links