FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2

The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age

argenx reports positive phase 3 ADAPT SERON results of VYVGART in AChR-Ab seronegative gMG

VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications

Johnson & Johnson submits additional data to FDA on psoriatic arthritis

The submission is supported by results from the Phase 3b APEX study

Imfinzi granted Priority Review and Breakthrough Therapy Designation in US

For patients with resectable early-stage gastric and gastroesophageal junction cancers

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease

FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL

Approval is based on positive data from the Phase 3 ECHELON-3 trial

BMS receives positive CHMP opinion for Opdivo plus Yervoy as a first-line treatment option for advanced hepatocellular carcinoma

Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population

FDA accepts supplemental Biologics License Application for Roche’s Columvi combination

For people with relapsed or refractory diffuse large B-cell lymphoma

New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions

Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant