HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

By adding specialists to USPSTF, Kennedy would reshape the functioning and decisions of the influential health panel
Ransohoff: “The task force’s job is to describe the evidence fairly, and that’s done best with objective, detached methodologists”

Health and Human Services Secretary Robert F. Kennedy Jr. is moving to overhaul the U.S. Preventive Services Task Force, a highly influential panel that determines which preventive services insurers must cover and guides routine medical care for millions of Americans.

May 01, 2026

Vol.52 No.17

By Claire Marie Porter

Regulatory News

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

HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down

The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

YOU MAY BE INTERESTED IN

By adding specialists to USPSTF, Kennedy would reshape the functioning and decisions of the influential health panel
Ransohoff: “The task force’s job is to describe the evidence fairly, and that’s done best with objective, detached methodologists”

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

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HHS presents new protein-forward dietary guidelines, turning the food pyramid upside down

The Kennedy guidelines are mum on cancer risks associated with red meat and alcohol

YOU MAY BE INTERESTED IN

By adding specialists to USPSTF, Kennedy would reshape the functioning and decisions of the influential health panelRansohoff: “The task force’s job is to describe the evidence fairly, and that’s done best with objective, detached methodologists”

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

Never miss an issue!

Login

By adding specialists to USPSTF, Kennedy would reshape the functioning and decisions of the influential health panel
Ransohoff: “The task force’s job is to describe the evidence fairly, and that’s done best with objective, detached methodologists”

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