FDA approves Darzalex Faspro for high-risk smoldering multiple myeloma

FDA final guidance on psychedelics opens the door to psycho-oncology research
Guidance permits treatment without psychotherapy, alarming scientists, advocates

FDA has released a final guidance for drug sponsors conducting clinical trials of psychedelics, including psilocybin, LSD, and MDMA, for the treatment of psychiatric and substance abuse disorders.

House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

At a recent House Energy and Commerce Health Subcommittee hearing titled “Maintaining America’s Leadership in Biomedical Innovation: FDA’s Role in Advancing U.S. Drug Development,” lawmakers examined ways to increase efficiency and speed across early-stage clinical trial development.

July 17, 2026

Vol.52 No.28

By Claire Marie Porter

Clinical Roundup

Lenalidomide maintenance may end after two years for patients with MM, phase III trial finds

For patients with newly diagnosed multiple myeloma not undergoing an autologous stem cell transplant, indefinite lenalidomide maintenance has long been standard of care, despite limited evidence to guide the optimal duration of treatment.

July 17, 2026

Vol.52 No.28

Drugs & Targets

FDA approves Padcev + Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility

FDA approved Padcev (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus the PD-1 inhibitor Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph), as neoadjuvant and adjuvant treatment for adult patients with muscle-invasive bladder cancer, regardless of cisplatin eligibility.

July 17, 2026

Vol.52 No.28

Drugs & Targets

FDA approves Revtorpyk for HR+/HER2-, PIK3CA wild-type, locally advanced or metastatic breast cancer

FDA approved Revtorpyk (gedatolisib) for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Revtorpyk is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval.

July 17, 2026

Vol.52 No.28

Drugs & Targets

FDA approves Sarclisa Escena for subcutaneous injection for multiple indications in MM

FDA approved Sarclisa Escena (isatuximab-irfc) for subcutaneous injection for multiple myeloma indications.

July 17, 2026

Vol.52 No.28

FDA approves Darzalex Faspro for high-risk smoldering multiple myeloma

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FDA final guidance on psychedelics opens the door to psycho-oncology research
Guidance permits treatment without psychotherapy, alarming scientists, advocates

House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

Lenalidomide maintenance may end after two years for patients with MM, phase III trial finds

FDA approves Padcev + Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility

FDA approves Revtorpyk for HR+/HER2-, PIK3CA wild-type, locally advanced or metastatic breast cancer

FDA approves Sarclisa Escena for subcutaneous injection for multiple indications in MM

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FDA approves Darzalex Faspro for high-risk smoldering multiple myeloma

YOU MAY BE INTERESTED IN

FDA final guidance on psychedelics opens the door to psycho-oncology researchGuidance permits treatment without psychotherapy, alarming scientists, advocates

House Energy & Commerce hearing focuses on America’s leadership in biomedical research, examines FDA role

Lenalidomide maintenance may end after two years for patients with MM, phase III trial finds

FDA approves Padcev + Keytruda for muscle-invasive bladder cancer regardless of cisplatin eligibility

FDA approves Revtorpyk for HR+/HER2-, PIK3CA wild-type, locally advanced or metastatic breast cancer

FDA approves Sarclisa Escena for subcutaneous injection for multiple indications in MM

Never miss an issue!

Login

FDA final guidance on psychedelics opens the door to psycho-oncology research
Guidance permits treatment without psychotherapy, alarming scientists, advocates