Seres Therapeutics Receives Feedback From FDA on SER-155 Allogeneic Hematopoietic Stem Cell Transplant (allo-HSCT) Development Approach
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 ...
Nasdaq2d
Outlook Therapeutics Resubmits BLA For ONS-5010 To FDA In Wet AMD
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 ...
Nasdaq5d
FDA Accepts BLA Reubmission For Regeneron's Odronextamab In Follicular Lymphoma
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 ...
Nasdaq4d
Opus Genetics Announces FDA Fast Track, Trial Enrollment Updates For Phentolamine 0.75%
(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 ...
Nasdaq11d
FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address TICE® BCG Shortage
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 ...
Nasdaq13d
Spectral AI Strengthens Financial Position Ahead of FDA Submission
DALLAS, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI ... Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI ...
Nasdaq6d
Mirum Pharma's CTEXLI Gets FDA Approval For Treatment Of Adults With Cerebrotendinous Xanthomatosis
"The FDA's approval of CTEXLI is tremendous as it ... 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 ...
Nasdaq5d
Telix Pharma : FDA Accepts BLA For TLX250-CDx For Kidney Cancer Imaging
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 ...
Nasdaq10d
Teva Pharmaceuticals and Alvotech Announce FDA Approval of SELARSDI™ Biosimilar for Multiple Indications
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 ...
Nasdaq7d
Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment
NLS Pharmaceutics Ltd. (Nasdaq: NLSP”) (“NLS”) and Kadimastem ... with a committee of the U.S Food and Drug Administration (“FDA”) on February 24, 2025, regarding the development of ...
Nasdaq29d
Is Vertex Pharmaceuticals a Buy Now That the FDA Approved Its New Pain Drug?
Shares of Vertex Pharmaceuticals (NASDAQ: VRTX) are down about 9% from a peak the stock set in November, despite some highly positive news. The U.S. Food and Drug Administration (FDA) approved ...
Nasdaq12d
Gilead Sciences: FDA To Review NDA Submissions For Lenacapavir - Quick Facts
The FDA will review the applications under priority ... and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New ...