Pharmafile Logo
T40 2022 Cover
Diversity, Equity and Inclusion
Communiqué 53 Cover Image
- PMLiVE

clinical trials

- PMLiVE

J&J and Legend’s Carvykti approved by FDA for expanded multiple myeloma use

The cell therapy is the first and only BCMA-targeted therapy to be approved for this condition as early as first relapse

- PMLiVE

AstraZeneca/Daiichi Sankyo’s Enhertu granted FDA accelerated approval for solid tumours

The ADC has been authorised to treat adults with unresectable or metastatic HER2-positive tumours

- PMLiVE

AstraZeneca’s Voydeya granted FDA approval for rare blood disease PNH

Up to 20% of patients treated with C5 inhibitors experience clinically significant extravascular haemolysis

- PMLiVE

FDA grants Invivyd’s Pemgarda emergency use authorisation for COVID-19 prevention

The long-acting monoclonal antibody is authorised for use in adults and adolescents

- PMLiVE

Merck’s Winrevair granted FDA approval to treat pulmonary arterial hypertension in adults

The rare blood vessel disorder affects approximately 500 to 1,000 people in the US every year

- PMLiVE

AstraZeneca’s Ultomiris receives FDA approval to treat rare autoimmune disease NMOSD

Neuromyelitis optica spectrum disorder is estimated to affect approximately 6,000 adults in the US

- PMLiVE

Johnson & Johnson’s Opsynvi granted FDA approval in pulmonary arterial hypertension

The rare form of pulmonary hypertension is responsible for up to 1,000 new cases in the US every year

- PMLiVE

AbbVie’s Elahere granted full FDA approval for previously-treated ovarian cancer

The company recently gained access to the therapy through its $10.1bn acquisition of ImmunoGen

- PMLiVE

FDA approves Italfarmaco’s Duvyzat as first nonsteroidal Duchenne muscular dystrophy drug

The neuromuscular genetic disease is estimated to affect one in every 3,500 to 6,000 male births worldwide

- PMLiVE

Takeda’s Iclusig combination granted FDA accelerated approval for rare form of leukaemia

The drug is now the first targeted therapy approved as a frontline treatment for Ph-positive ALL

- PMLiVE

FDA approves Orchard’s Lenmeldy gene therapy for metachromatic leukodystrophy

The rare genetic disease is estimated to affect one in every 40,000 people in the US

- PMLiVE

FDA approves Madrigal’s Rezdiffra as first drug for fatty liver disease NASH

Over six million people in the US are affected by NASH with moderate-to-advanced liver scarring

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links