Drug Approval | October 01, 2025
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
BPDCN is a challenging blood cancer with characteristics of both leukemia and lymphoma
Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD
The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing
The submission is supported by results from the Phase 3b APEX study
For patients with resectable early-stage gastric and gastroesophageal junction cancers
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
Capricor’s BLA for Deramiocel received Priority Review in March 2025
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