FDA grants Fast Track designation to IO-202, anti-LILRB4 myeloid checkpoint inhibitor for AML

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

Earlier this year, Joe Rogan, host of “The Joe Rogan Experience” podcast, sent a text to President Donald Trump.

June 18, 2026

FDA clears a way for dramatic reduction in animal toxicology studies in cancer

FDA has issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for some cancer pharmaceuticals.

June 18, 2026

Vol.52 No.24

By Claire Marie Porter

Clinical Roundup

All-oral regimen of decitabine-cedazuridine + venetoclax yields 47% complete response rate, ASCERTAIN-V phase I/II clinical trial finds

The ASCERTAIN-V phase I/II clinical trial, which evaluated the first all-oral regimen of decitabine-cedazuridine plus venetoclax in patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive induction chemotherapy, demonstrated favorable response rates and survival with expected myelosuppressive effects.

June 18, 2026

Vol.52 No.24

Clinical Roundup

Jaypirca + venetolax + rituximab reduced the risk of disease progression or death by 45% in r/r CLL/SLL, phase III BRUIN CLL-322 trial finds

Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase inhibitor, plus a two-year venetoclax and rituximab regimen versus venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma reduced the risk of disease progression or death by 45% (HR=0.55 [95% CI, 0.40-0.75]; p=0.0001), according to the results of the phase III BRUIN CLL-322 trial. The study met its primary endpoint of independent review committee-assessed progression-free survival.

June 18, 2026

Vol.52 No.24

Drugs & Targets

FDA approves Ambelvist for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity

FDA has approved Ambelvist (gadoquatrane), an intravenous macrocyclic gadolinium-based contrast agent indicated for contrast-enhanced magnetic resonance imaging to detect and visualize lesions with abnormal vascularity in the central nervous system and non-CNS body regions in adult and pediatric patients, including term neonates.

June 18, 2026

Vol.52 No.24

Drugs & Targets

FDA accepts sBLA for atezolizumab for patients with stage 3 dMMR colon cancer

FDA has accepted for review Genentech’s supplemental Biologic License Application for their immunotherapy drug atezolizumab (Tecentriq) for the treatment of patients with stage 3 colon cancer with deficient deoxyribonucleic acid mismatch repair.

June 18, 2026

Vol.52 No.24

FDA grants Fast Track designation to IO-202, anti-LILRB4 myeloid checkpoint inhibitor for AML

YOU MAY BE INTERESTED IN

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

FDA clears a way for dramatic reduction in animal toxicology studies in cancer

All-oral regimen of decitabine-cedazuridine + venetoclax yields 47% complete response rate, ASCERTAIN-V phase I/II clinical trial finds

Jaypirca + venetolax + rituximab reduced the risk of disease progression or death by 45% in r/r CLL/SLL, phase III BRUIN CLL-322 trial finds

FDA approves Ambelvist for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity

FDA accepts sBLA for atezolizumab for patients with stage 3 dMMR colon cancer

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FDA grants Fast Track designation to IO-202, anti-LILRB4 myeloid checkpoint inhibitor for AML

YOU MAY BE INTERESTED IN

Is psilocybin heading to a cancer clinic near you?Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research

FDA clears a way for dramatic reduction in animal toxicology studies in cancer

All-oral regimen of decitabine-cedazuridine + venetoclax yields 47% complete response rate, ASCERTAIN-V phase I/II clinical trial finds

Jaypirca + venetolax + rituximab reduced the risk of disease progression or death by 45% in r/r CLL/SLL, phase III BRUIN CLL-322 trial finds

FDA approves Ambelvist for contrast-enhanced MRI to detect and visualize lesions with abnormal vascularity

FDA accepts sBLA for atezolizumab for patients with stage 3 dMMR colon cancer

Never miss an issue!

Login

Is psilocybin heading to a cancer clinic near you?
Reversing Nixon-era taboo, Trump orders FDA to fast-track psychedelics and ARPA-H to fund research