The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn ...

Please provide your email address to receive an email when new articles are posted on . Briquilimab depletes the mast cells that release inflammatory mediators. Patients reported improvements in ...

AI-guided, synthetic lethal therapy achieves complete metabolic response after just two cycles in patient who failed three prior state-of-the-art treatment regimens. Complete response in an aggressive ...

Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window Many patients ...

Cretostimogene shows promising efficacy in bladder cancer treatment, with 75.5% complete response rate and sustained duration of over 28 months. CG Oncology, Inc. announced encouraging results from ...

NOVATO, Calif., July 11, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (RARE), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) ...

CG Oncology, Inc. (NASDAQ:CGON) announced on Saturday that cretostimogene grenadenorepvec monotherapy data were presented at the 2025 American Urological Association Annual Meeting. The Phase 3 ...

Pathologic complete response shows poor surrogacy for overall survival (OS) in neoadjuvant breast cancer (BC) trials, while invasive disease-free survival demonstrates moderate to strong association ...

Association between combination of VI-RADS based on T2WI and morphological features and pathological outcome and prognosis in bladder cancer. This is an ASCO Meeting Abstract from the 2025 ASCO ...

Ultragenyx received a Complete Response Letter from the FDA regarding its UX111 therapy for Sanfilippo syndrome type A, citing manufacturing observations. Ultragenyx Pharmaceutical Inc. announced that ...