Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Shots: Ahsan spoke about the US FDA acceptance for Priority Review of sBLAs for PADCEV and KEYTRUDA to treat patients with LA/mUC who are not eligible to receive cisplatin-containing CT He also talked about the study design and outcomes from the P-Ib/II (EV-103) clinical trial that supported the sBLA. The results from Dose Escalation/Cohort A…

BySenior EditorAugust 17, 2023

Insights+: The US FDA New Drug Approvals in April 2023

Shots: The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

Disease of the Month: Cervical Cancer

“Get Informed, Get Screened, Get Vaccinated” – WHO Introduction: Cervical cancer is the 4th most common cancer among women and 7th most commonly occurring cancer overall. When a malignant growth or tumor occurs in the cells lining the walls of the cervix, it is called cervical cancer. The cervix is the narrow, lower part of the uterus…

BySenior EditorJanuary 12, 2023

Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Insights+: The US FDA New Drug Approvals in April 2023

Disease of the Month: Cervical Cancer

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