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 ...

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 ...

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

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 ...

Q4 2024 Earnings Call Transcript February 28, 2025 Longeveron Inc. beats earnings expectations. Reported EPS is $1.16, ...

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 ...

Q2 2025 Earnings Call Transcript February 28, 2025 Silviu Itescu: Good morning, everybody. I’m Silviu Itescu. I’m the Chief ...

(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 ...

(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 28, 2025 Operator: Good afternoon, everyone. Welcome to the Crinetics ...

Q4 2024 Earnings Call Transcript February 27, 2025 Altimmune, Inc. beats earnings expectations. Reported EPS is $-0.33, ...