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 ...

The FDA had previously issued a Complete Response ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...

(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 ...

(NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that alignment has been reached with the U.S. Food and Drug Administration (FDA) to ...

The FDA granted a Priority Review and provided a ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...

Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in ...

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 ...

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 ...

If approved, PRGN-2012 will be the first FDA-approved therapy for RRP ... Tuesday the stock is up by 16.57 percent at $2.04 on the Nasdaq. The views and opinions expressed herein are the views ...

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

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

Q4 2024 Earnings Call Transcript February 28, 2025 Operator: Good afternoon, everyone. Welcome to the Crinetics ...