FDA proposes rule aimed at ensuring safety and effectiveness of laboratory developed tests

Don’t confirm RFK Jr. for HHS, 77 Nobel laureates urge the Senate

Robert F. Kennedy Jr., President-elect Donald Trump’s choice for HHS secretary, is unfit for that role and should not be confirmed, 77 Nobel laureates said in a letter to members of the U.S. Senate.

December 13, 2024

Vol.50 No.46

By Yiqing Wang

Drugs & Targets

FDA approves durvalumab for LS-SCLC

FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

December 13, 2024

Vol.50 No.46

In Brief

Siemens Healthineers, Ohio State Wexner Medical Center form 10-year, $105M partnership

Siemens Healthineers and The Ohio State Wexner Medical Center have expanded their existing strategic relationship to form a 10-year, $105 million value partnership to foster breakthroughs in clinical care, in addition to their longstanding research collaboration.

December 06, 2024

Vol.50 No.45

Drugs & Targets

FDA grants accelerated approval to zenocutuzumab-zbco for NSCLC and pancreatic adenocarcinoma

FDA has granted accelerated approval to zenocutuzumab-zbco (Bizengri) for adults

December 06, 2024

Vol.50 No.45

Clinical Roundup

NCCN updates CML treatment guidelines following FDA approval of Scemblix for newly diagnosed patients

The National Comprehensive Cancer Network updated its chronic myeloid leukemia treatment guidelines, recommending Scemblix (asciminib) for the treatment of adults with newly diagnosed Ph+ CML-CP as a category 1-preferred.

November 22, 2024

Vol.50 No.44

Drugs & Targets

FDA approves new alternative standard related to mammography report assessments

FDA recently approved Alternative Standard #25 related to the Mammography Quality Standards Act. Alternative Standard #25 allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”

November 22, 2024

Vol.50 No.44

FDA proposes rule aimed at ensuring safety and effectiveness of laboratory developed tests

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Don’t confirm RFK Jr. for HHS, 77 Nobel laureates urge the Senate

FDA approves durvalumab for LS-SCLC

Siemens Healthineers, Ohio State Wexner Medical Center form 10-year, $105M partnership

FDA grants accelerated approval to zenocutuzumab-zbco for NSCLC and pancreatic adenocarcinoma

NCCN updates CML treatment guidelines following FDA approval of Scemblix for newly diagnosed patients

FDA approves new alternative standard related to mammography report assessments

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