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Exhibition booth Seattle Genetics - ASCO 2019 | Courtsey: Emila Duaerte / Sunvalley Communication

Enfortumab Vedotin Receives Regular Approval and an Expanded Indication for Locally...

The U.S. Food and Drug Administration (FDA) has granted regular approval for enfortumab vedotin-ejfv (Padcev®; Astellas Pharma and Seagen) while, at the same time,...

Withdrawal of FDA’s Accelerate Approved Therapeutic Agents may harm Patients

The United States Food and Drug Administration’s (FDA) program to accelerate approval of some promising therapeutic agents has recently come under fire due to...

Potential Accelerated Approval for Enfortumab Vedotin in Combination with Pembrolizumab as...

Updated data from the phase Ib/II multicohort EV-103 trial (NCT03288545; also known as KEYNOTE-869) of enfortumab vedotin* (Padcev™; Seattle Genetics/Astellas Pharma) in combination with...

FDA Grants Breakthrough Therapy Designation to Enfortumab Vedotin-ejfv in First-Line Advanced...

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enfortumab vedotin-ejfv (Padcev™; Astellas Pharma and Seattle Genetics) in combination with...

Accelerated Approval for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial...

The U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev™; Astellas Pharma / Seattle Genetics)* for the treatment of adult...

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