The firm's biologics license application for TLX250-CDx was granted priority review and a decision is expected in August.

Transitioned lead commercial responsibility of Nuvaxovid COVID-19 vaccine to Sanofi beginning with the 2025-2026 season Achieved total revenue of $88 million in ...

Q4 2024 Earnings Call Transcript February 26, 2025 Sarepta Therapeutics, Inc. beats earnings expectations. Reported EPS is $1.5, expectations were $1.38. Operator: Good afternoon. And welcome to the ...

Announced alignment with the U.S. Food and Drug Administration (FDA) on key elements of the Accelerated Approval pathway for AMT-130 in ...

The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for ...

PRGN-2012—which Precigen has begun to call by its generic name of zopapogene imadenovec—is a gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus ...

The FDA accepted odronextamab’s biologics license application resubmission for relapsed/refractory follicular lymphoma after ...

Regeneron Pharmaceuticals (NASDAQ:REGN) said on Wednesday that the U.S. FDA has accepted its resubmitted Biologics License ...

(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 ...

Telix Pharmaceuticals (TLX) stock in focus as company secures FDA priority review for TLX250-CDx, a PET imaging agent for ...

After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for ...

Shoals is highly profitable and generates significant operating cash flow relative to its debt balance, further supporting our view that its financial strength is sound. We assign a no-moat rating to ...