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

AMARANTH

- 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

Biogen’s Alzheimer’s treatment Aduhelm limited to clinical trial participants in the US

Biogen and The Alzheimer's Association fear that the approach will unfairly exclude patients from therapies and create further healthcare inequities

- 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

- PMLiVE

FDA rejects Takeda’s Eohilia after delays

After more than a year on ‘priority review’, the FDA has said it cannot approve Takeda’s budesonide oral suspension without a further clinical study

- PMLiVE

FDA approves Amgen’s Otezla for all patients with plaque psoriasis

The FDA has expanded use of Otezla to adults with mild to moderate plaque psoriasis, making it the first oral treatment for the skin condition, regardless of severity

- PMLiVE

AstraZeneca’s Saphnelo to be approved in Europe for lupus

The EMA is set to approve the first new treatment for systemic lupus erythematosus in Europe in more than a decade

- PMLiVE

Tezspire approved in US for severe asthma

AstraZeneca and Amgen’s monoclonal antibody Tezspire is now available to control dangerous exacerbations in all adults and children aged 12 years and above with severe asthma

- PMLiVE

FDA approves first drug to prevent graft-versus-host disease

Bristol Myers Squibb’s arthritis drug, Orencia, can now be given to adults and children undergoing stem cell transplants to prevent the life-threatening condition

- PMLiVE

Lilly and Foghorn sign oncology deal

Eli Lilly has teamed up with Foghorn Therapeutics to develop drugs that target the chromatin regulatory system using Foghorn's proprietary Gene Traffic Control platform

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links