On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager,...
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On June 12, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and paediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Selpercatinib received accelerated approval for this indication [...]
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...
Eli Lilly (LLY) wins FDA approval for its Alzheimer's disease drug, Kisunla. (donanemab). Sanofi (SNY) and Regeneron's Dupixent gets approval for COPD...
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...