FDA approves Xtandi for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.

May 30, 2025

Vol.51 No.21

Drugs & Targets

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

Alligator Bioscience on May 26 announced that the European Commission granted orphan drug designation to HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 is being developed by Shanghai Henlius Biotech, Inc. under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

May 30, 2025

Vol.51 No.21

Podcast

In The Headlines: Back to “business as usual” at FDA?

The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.

May 28, 2025

Vol.51 No.20

Regulatory News

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.

May 23, 2025

Vol.51 No.20

By Jacquelyn Cobb

Clinical Trials & Tribulations

Biden’s diagnosis is unfortunate but—statistically—not surprising
Of the 384 men serving in Congress, 48 are likely to be diagnosed with prostate cancer in their lifetime

Credit: Jonah Elkowitz/ShutterstockThat President Biden was diagnosed with prostate cancer is certainly unfortunate news, but it should come as no surprise. One in eight men in the U.S. will be told they have prostate cancer at some point in their lifetime: more than 300,000 new diagnoses occur annually, and the absolute numbers are rising.

FDA Commissioner Makary holds roundtable discussion on harms of talc

FDA Commissioner Marty Makary held a roundtable of independent scientific experts to discuss the safety and necessity of talc as an additive to food, drugs, and cosmetic products.

May 23, 2025

Vol.51 No.20

By Claire Marie Porter

FDA approves Xtandi for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

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FDA grants priority review for sevabertinib in HER2-mutant NSCLC

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

In The Headlines: Back to “business as usual” at FDA?

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

Biden’s diagnosis is unfortunate but—statistically—not surprising
Of the 384 men serving in Congress, 48 are likely to be diagnosed with prostate cancer in their lifetime

FDA Commissioner Makary holds roundtable discussion on harms of talc

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FDA approves Xtandi for non-metastatic castration-sensitive prostate cancer with biochemical recurrence

YOU MAY BE INTERESTED IN

FDA grants priority review for sevabertinib in HER2-mutant NSCLC

Alligator Bioscience announces European orphan drug designation for HLX22 in gastric cancer

In The Headlines: Back to “business as usual” at FDA?

ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session

Biden’s diagnosis is unfortunate but—statistically—not surprisingOf the 384 men serving in Congress, 48 are likely to be diagnosed with prostate cancer in their lifetime

FDA Commissioner Makary holds roundtable discussion on harms of talc

Never miss an issue!

Login

Biden’s diagnosis is unfortunate but—statistically—not surprising
Of the 384 men serving in Congress, 48 are likely to be diagnosed with prostate cancer in their lifetime