On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager,...

Bristol Myers (BMY) wins FDA approval for Krazati, in combination with Erbitux, as a targeted treatment option for adult patients with...

Breast cancer is a complex disease with varying degrees of severity and treatment approaches. Central to understanding and managing breast cancer is...

MONDAY, June 24, 2024 -- The U.S. Food and Drug Administration has expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene...

June 24, 2024 -- The U.S. Food and Drug Administration (FDA) has approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients...

BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...

Per the FDA, Rocket (RCKT) needs to submit additional manufacturing information on Kresladi gene therapy to secure approval for severe leukocyte...

AbbVie (ABBV) is seeking approval for Tepkinly in the EU as a monotherapy for the treatment of adult patients with relapsed/refractory follicular...

COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved...

Eli Lilly's (LLY) Alzheimer's disease drug, Kisunla (donanemab), wins FDA approval. Kisunla will be the second drug on the market to treat the...