ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority

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

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

Drugs & Targets

FDA approves revumenib for r/r acute leukemia with a KMT2A translocation

FDA approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.

November 22, 2024

Vol.50 No.44

ODAC reviews two longest-running accelerated approvals as FDA weighs using its new authority

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

FDA approves durvalumab for LS-SCLC

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

FDA approves revumenib for r/r acute leukemia with a KMT2A translocation

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