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- PMLiVE

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- PMLiVE

NICE recommends AZ’s Forxiga for kidney disease

The recommendation is based on results from a phase 3 trial

- 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 Imfinzi and tremelimumab show unprecedented survival rate in liver cancer patients

The phase 3 trial results for patients diagnosed with first-line unresectable liver cancer showed a 31% survival rate after three years

- 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

AstraZeneca’s Vaxzevria trial provides further support for protection against COVID-19 variants

New data from continued testing has shown that a third booster of Vaxzevria supports an increased antibody response against SARS-CoV-2 variants

- 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

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

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