Denali clinches $275 million royalty deal to power potential breakthrough Hunter Syndrome therapy

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

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability

AbbVie seeks FDA approval for Pivekimab Sunirine to treat rare, aggressive blood cancer

BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD

FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease

The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease

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

Boehringer and AnGes sign manufacturing agreement for HGF gene therapy product

Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing

Johnson & Johnson submits additional data to FDA on psoriatic arthritis

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