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

Aveo Oncology

- PMLiVE

No green light from NICE for innovative cancer treatments

The Institute of Cancer Research is asking for more flexibility and consideration to make it easier for cancer patients to access new treatments on the NHS

- PMLiVE

FDA issues approval for Janssen’s HIV drug Cabenuva

The injectable treatment for adults with HIV can be administered every two months

- PMLiVE

FDA places partial clinical hold on three Gilead phase 3 trials for MDS and AML treatments

The company confirmed that six other phase 2 trials would go ahead as previously planned

- PMLiVE

FDA restricts use of certain antibody treatments for COVID-19

The restrictions reflect recent data that shows these antibodies are not effective against the Omicron variant

- PMLiVE

FDA grants priority review for Roche’s Evrysdi for spinal muscular atrophy in babies

The review of Evrysdi has been developed for pre-symptomatic babies under two months old with spinal muscular atrophy

- PMLiVE

Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19

The FDA also issued an EUA for the treatment to include non-hospitalised paediatric patients 12 years and under who are at high risk of disease progression

- PMLiVE

AstraZeneca’s Enhertu receives FDA grant for priority review

The approval is based on results from the DESTINY-Breast03 trial which showed a significant risk reduction of unresectable or metastatic HER-2 positive breast cancer progression

- PMLiVE

Pfizer’s Cibinqo granted FDA approval for adults with moderate-to-severe atopic dermatitis

The FDA based its approval on results from a clinical trial programme involving over 1,600 patients

- PMLiVE

BMS and Century Therapeutics agree on deal potentially worth over $3bn

The collaboration unites Century’s iPSC-derived allogeneic cell therapy line with BMS’s record in developing oncology drugs and cell therapies

- PMLiVE

Amgen’s Lumykras receives conditional marketing authorisation from EC

The drug is the first targeted therapy for patients diagnosed with advanced NSCLC with the KRAS G12C mutation

- PMLiVE

Sanofi and Exscientia agree on a deal worth up to $5.2bn for AI-driven therapies

The strategic research collaboration between the two companies aims to develop AI-driven pipeline of precision-engineered therapies

- PMLiVE

Pfizer/BioNTech receives expanded authorisation from the FDA for its COVID-19 booster

The booster dose of the companies’ COVID-19 vaccine is now authorised to include individuals aged 12 years and older

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links