Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

FDA advisory panel recommends first-of-its-kind mRNA flu vaccine for older adults

An FDA advisory panel has recommended approval of Moderna’s mRNA-based flu vaccine, mFlusiva, for adults ages 50-64, and adults 65 and older, if a specific condition is met.

June 26, 2026

Vol.52 No.25

By Claire Marie Porter

Drugs & Targets

FDA approves Tecelra for pediatric synovial sarcoma

FDA granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

June 26, 2026

Vol.52 No.25

Podcast

Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

In this week's episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher, and Sara Willa Ernst, reporter, go on a trip into the world of federal health policy surrounding psychedelic medicine.

June 24, 2026

Regulatory News

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.

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FDA has issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for some cancer pharmaceuticals.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

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

Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

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FDA advisory panel recommends first-of-its-kind mRNA flu vaccine for older adults

FDA approves Tecelra for pediatric synovial sarcoma

Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

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

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

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Bayer submits sNDA to FDA for expanded indication for Nubeqa for treatment of mHSPC

YOU MAY BE INTERESTED IN

FDA advisory panel recommends first-of-its-kind mRNA flu vaccine for older adults

FDA approves Tecelra for pediatric synovial sarcoma

Policy by way of podcaster—FDA issues priority vouchers after Joe Rogan episode on psychedelics

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

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

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