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Acrotech Biopharma LLC

Latest From Acrotech Biopharma LLC

Yo-Yo Approvals? Maybe Accelerated Approval Isn’t Fixed After All

Oncopeptides’ reversal on Pepaxto may or may not prove to be the right decision – but it underscores the inherent limits to US FDA’s efforts to police ‘dangling’ accelerated approvals.

Review Pathway Cancer

Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA

After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.

Clinical Trials Drug Approval Standards

‘Dangling’ Cancer Indications In US: New Year Brings New Withdrawals Of Accelerated Approvals

Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.

Clinical Trials Review Pathway

Keeping Track: US FDA Clears On Target’s Cytalux, VBI’s PreHevbrio; Keytruda Grows In Adjuvant Melanoma

The latest FDA approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals
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