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

simvastatin

- PMLiVE

AstraZeneca’s Imjudo/Imfinzi combination approved by FDA for unresectable liver cancer

Phase 3 trial results demonstrated a 22% reduction in risk of death versus sorafenib

- PMLiVE

Merck’s Prevymis shows promise in phase 3 cytomegalovirus disease prevention trial

The drug demonstrated non-inferior efficacy compared to standard of care valganciclovir

- PMLiVE

Novavax’s COVID-19 vaccine candidate approved for emergency use by FDA as a booster

The authorisation is for those unable to receive an FDA-authorised mRNA bivalent booster

- PMLiVE

Merck and Bill & Melinda Gates Institute sign licensing agreement for tuberculosis candidates

The non-profit will determine their potential for inclusion in new affordable treatment regimens

- PMLiVE

FDA awards over $38m for advancement of rare disease treatments

Grants will support clinical trials, natural history studies and regulatory science tools

Biomarin

BioMarin’s application for haemophilia A gene therapy accepted by FDA

If approved, the treatment would be the first gene therapy in the US for this indication

- PMLiVE

Merck and Moderna to jointly develop personalised cancer vaccine in $250m deal

The vaccine is currently being evaluated as a treatment for high-risk melanoma patients

- PMLiVE

Pfizer/BioNTech BA.4/BA.5 COVID-19 booster approved for emergency use by FDA in children five to 11 years

The doses will be shipped immediately, pending recommendation from the CDC

- PMLiVE

Genentech shares positive two-year data for Evrysdi in spinal muscular atrophy study

The study enrolled the ‘broadest and most diverse’ patient population ever studied in an SMA trial

regeneron headquarters

Regeneron’s application for Eylea in retinopathy of prematurity accepted for FDA priority review

The rare eye disease often impacts infants who are born before 31 weeks of pregnancy

- PMLiVE

Eli Lilly granted fast track designation by FDA for obesity treatment

The company plans to initiate a rolling submission of a new drug application for tirzepatide this year

- PMLiVE

InflaRx seeks FDA authorisation for vilobelimab for critically ill COVID-19 patients

A phase 3 study showed that the antibody reduced the all-cause mortality rate after 28 days

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links