Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

Angelo de Claro named acting director of FDA Oncology Center of Excellence

Angelo de Claro was named acting director of the FDA Oncology Center of Excellence, following Richard Pazdur’s departure from that position—and the agency (The Cancer Letter, Dec. 5, 2025).

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

FDA has approved rucaparib (Rubraca) for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy.

December 19, 2025

Vol.51 No.46

Drugs & Targets

FDA and OS Therapies hold Type C meeting regarding phase IIb clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma

FDA and OS Therapies held a Type C meeting regarding the phase IIb human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma.

December 19, 2025

Vol.51 No.46

Drugs & Targets

FDA awards National Priority Voucher to Tecvayli+Darzalex based on phase III study results

FDA has awarded a National Priority Voucher to teclistamab (Tecvayli) in combination with daratumumab (Darzalex) for relapsed/refractory multiple myeloma. This brings the total number of products receiving an award under the Commissioner’s National Priority Voucher pilot program to 16.

December 19, 2025

Vol.51 No.46

Podcast

Testing for asbestos in talc-based cosmetics seems like a no-brainer—why did FDA withdraw a rule to standardize it?

Last month, FDA withdrew a proposed rule for standardized asbestos testing in talc-based cosmetics. The proposed rule, introduced in Nov. 2024 and withdrawn Nov. 2025, was mandated by the Modernization of Cosmetics Regulation Act of 2022 or MoCRA.

December 17, 2025

Regulatory News

FDA withdraws proposed rule for asbestos testing in talc-based cosmetics
It’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation

FDA has withdrawn a proposed rule that called for standardized testing for detecting and identifying asbestos in talc-containing cosmetic products.

December 12, 2025

Vol.51 No.45

By Claire Marie Porter

Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations

BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

YOU MAY BE INTERESTED IN

Angelo de Claro named acting director of FDA Oncology Center of Excellence

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

FDA and OS Therapies hold Type C meeting regarding phase IIb clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma

FDA awards National Priority Voucher to Tecvayli+Darzalex based on phase III study results

Testing for asbestos in talc-based cosmetics seems like a no-brainer—why did FDA withdraw a rule to standardize it?

FDA withdraws proposed rule for asbestos testing in talc-based cosmetics
It’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation

Renew today!

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Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulations

BIO calls for the end of “constant turmoil,” urges the administration to “right the ship”

YOU MAY BE INTERESTED IN

Angelo de Claro named acting director of FDA Oncology Center of Excellence

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

FDA and OS Therapies hold Type C meeting regarding phase IIb clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma

FDA awards National Priority Voucher to Tecvayli+Darzalex based on phase III study results

Testing for asbestos in talc-based cosmetics seems like a no-brainer—why did FDA withdraw a rule to standardize it?

FDA withdraws proposed rule for asbestos testing in talc-based cosmeticsIt’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation

Never miss an issue!

Login

FDA withdraws proposed rule for asbestos testing in talc-based cosmetics
It’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation