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

priority review

- PMLiVE

FDA publishes final industry guidance for CAR-T and gene therapies

The new guidance can also be applied to other genetically modified lymphocyte products, including  CAR NK cells

- PMLiVE

GSK partners with DNA specialist Elegen to advance medicines and vaccines

GSK will leverage Elegen’s cell-free synthetic DNA production technology

- PMLiVE

GSK’s Omjjara approved by EC to treat myelofibrosis patients with anaemia

About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis

- PMLiVE

Sanofi/Regeneron’s Dupixent approved by FDA for younger eosinophilic oesophagitis patients

Around 21,000 children aged under 12 years in the US are being treated for the inflammatory disease

- PMLiVE

Johnson & Johnson’s bladder cancer drug Balversa granted full FDA approval

Urothelial carcinoma accounts for approximately 90% of bladder cancer cases

- PMLiVE

FDA grants fast track designation to Nurix’s BTK degrader for non-Hodgkin lymphomas

CLL is one of the most common types of leukaemia in adults, with around 18,740 new cases in the US last year

- PMLiVE

Takeda’s HyQvia granted FDA approval to treat rare neuromuscular disorder CIDP

Approximately five to seven people per 100,000 in the US are affected by the disorder

- PMLiVE

Sanofi/Regeneron’s Dupixent gets US label update for atopic dermatitis

Dupixent’s label now includes data supporting its use in hand and foot atopic dermatitis

- PMLiVE

FDA approves Vertex/CRISPR’s Casgevy gene therapy for beta thalassaemia

The companies estimate that approximately 1,000 patients in the US will be eligible for the one-time treatment

- PMLiVE

GSK to expand respiratory pipeline with $1.4bn Aiolos Bio acquisition

The deal includes a monoclonal antibody ready to enter phase 2 development for asthma

- PMLiVE

Merck granted FDA approval for Keytruda combination in cervical cancer

The decision marks the third FDA-approved indication for Keytruda in cervical cancer

- PMLiVE

AstraZeneca/Sanofi’s RSV treatment shown to reduce hospitalisations in infants

Beyfortus showed an over 80% reduction in hospitalisations associated with the virus

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links