FDA has provided input on key elements of the SER-155 allo-HSCT clinical development plans including support for the proposed primary efficacy endpoint of reduction in bloodstream infections (BSIs) as ...

ImmunityBio (NASDAQ:IBRX) stock rose 10% Friday morning after the company said it has received Regenerative Medicine Advanced ...

In the previous submission, the FDA had issued a complete response letter ... of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan ...

Shares of Altimmune Inc. (ALT) soared over 8% on Thursday, marking their best session in nearly three months, and extended ...

The FDA's provisional determination of interchangeability ... Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced the availability of SELARSDI (ustekinumab-aekn ...

Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted ...

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the U.S. Food and Drug Administration (FDA) has authorized an expanded ...

(RTTNews) - Opus Genetics, Inc. (IRD) announced Wednesday that its Phentolamine Ophthalmic Solution 0.75 percent has been granted Fast Track designation by the U.S. FDA. This designation is for ...

Shares of Viatris (NASDAQ:VTRS) slipped ~12% in the premarket on Thursday after the generic drugmaker, with its Q4 2024 ...

Pyxis Oncology (PYXS) stock rises as the FDA issues fast track designation for its lead asset PYX-201 in head and neck cancer ...

(RTTNews) - Indivior PLC (INDV) announced the FDA has approved label changes for ... the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan ...

Q4 2024 Earnings Call Transcript February 27, 2025 Verona Pharma plc misses on earnings expectations. Reported EPS is $-0.4 ...