FDA approves companion diagnostic for Opdivo for ESCC and GEJ, gastric, and esophageal adenocarcinoma

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

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

Drugs & Targets

FDA issues CRL for rivoceranib + camrelizumab as a first-line treatment for unresectable or metastatic HCC

FDA issued a complete response letter to Elevar Therapeutics Inc. regarding its new drug application for the combination of rivoceranib, an oral TKI, and camrelizumab, an anti-PD-1 antibody, as a first-line systemic treatment option for unresectable or metastatic hepatocellular carcinoma.

July 17, 2026

Vol.52 No.28

FDA approves companion diagnostic for Opdivo for ESCC and GEJ, gastric, and esophageal adenocarcinoma

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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

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

FDA issues CRL for rivoceranib + camrelizumab as a first-line treatment for unresectable or metastatic HCC

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FDA approves companion diagnostic for Opdivo for ESCC and GEJ, gastric, and esophageal adenocarcinoma

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

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

FDA issues CRL for rivoceranib + camrelizumab as a first-line treatment for unresectable or metastatic HCC

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