The leading Merkel Cell Carcinoma Companies such as ImmunityBio, OncoSec Medical, Exelixis, 4SC, Kartos Therapeutics, Incyte ...

The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application ...

Jeremy Walsh is now heading up artificial intelligence and information technology in a newly created position at the FDA.

The FDA issued an RTF for sBLA of nogapendekin alfa plus BCG for BCG-unresponsive NMIBC papillary disease, following prior ...

The market expects Ovid Therapeutics (OVID) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus ...

ImmunityBio, Inc. (NASDAQ:IBRX), operating in the biotechnology sector, is listed under the NASDAQ and is part of the nasdaq ...

BioCryst posted $134.2 million in Q1 revenue, raised 2025 Orladeyo guidance, and now expects full-year profitability and ...

ImmunityBio's sBLA for Anktiva was unexpectedly rejected by the FDA, contradicting prior positive feedback and approval for a ...

Shares of ImmunityBio, Inc. (IBRX) tumbled 18% on Monday afternoon after the company announced that it received a Refuse to ...

The RTF letter was unexpected, especially considering the positive feedback and unanimous encouragement ImmunityBio received ...

Shares of ImmunityBio touched a 52-week low after the company received a refusal-to-file letter from the Food and Drug Administration for a supplemental biologics license application for ...

CG Oncology Inc.’s latest research effort to treat bladder cancer is impressing investors.The Irvine-based biopharmaceutical ...