Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

Disappointment hangs in the air as Replimune’s Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab in the treatment of advanced melanoma was denied again by FDA on April 10.

CDC’s recommendation to delay infant hepatitis B shot is likely to raise infections, JAMA studies show

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, voted in December to rescind its recommendation that all newborns receive a hepatitis B virus vaccine dose within 24 hours of birth.

May 01, 2026

Vol.52 No.17

By Claire Marie Porter

Drugs & Targets

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

The FDA Oncologic Drugs Advisory Committee on April 30 considered two applications from AstraZeneca Pharmaceuticals LP.

FDA accepts NDA for zipalertinib for NSCLC with mutations

FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.

May 01, 2026

Vol.52 No.17

Drugs & Targets

FDA grants priority review for Ziihera in first-line HER2+ GEA

FDA has accepted for filing with Priority Review the supplemental Biologics License Application for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma.

May 01, 2026

Vol.52 No.17

Drugs & Targets

Unfold AI’s prostate cancer mapping added to regional CMS Physician Fee Schedule

Unfold AI, an AI prostate cancer mapping and clinical decision support platform, is now included in Medicare’s Physician Fee Schedules across the West Coast and Mountain West regions. The regional expansion of Medicare payment for the tool gives urologists and care teams clearer reimbursement pathways in physician office settings, an area that has historically lagged behind hospital outpatient settings for emerging technologies.

May 01, 2026

Vol.52 No.17

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

YOU MAY BE INTERESTED IN

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

CDC’s recommendation to delay infant hepatitis B shot is likely to raise infections, JAMA studies show

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

FDA accepts NDA for zipalertinib for NSCLC with mutations

FDA grants priority review for Ziihera in first-line HER2+ GEA

Unfold AI’s prostate cancer mapping added to regional CMS Physician Fee Schedule

Renew today!

Subscriber content

Never miss an issue!

Login

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

YOU MAY BE INTERESTED IN

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients“Patients are owed another review.”

CDC’s recommendation to delay infant hepatitis B shot is likely to raise infections, JAMA studies show

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

FDA accepts NDA for zipalertinib for NSCLC with mutations

FDA grants priority review for Ziihera in first-line HER2+ GEA

Unfold AI’s prostate cancer mapping added to regional CMS Physician Fee Schedule

Never miss an issue!

Login

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”