metastatic castration-resistant prostate cancer Archives

Jul 15, 2025

Nanoscope’s MCO-010 Begins FDA Rolling Submission for Retinitis Pigmentosa; Bayer’s KERENDIA Approved by FDA for Heart Failure With Preserved Ejection Fraction; Klotho Neurosciences’ KLTO-202 Receives FDA Orphan Drug Designation for ALS; Trethera’s TRE-515 Granted FDA Fast Track Designation for Metastatic Prostate Cancer; Adcentrx’s ADRX-0405 Awarded FDA Orphan Drug Designation for Gastric Cancer

Nanoscope Therapeutics Begins FDA Rolling Submission for MCO-010 in Retinitis Pigmentosa Nanoscope Therapeutics has initiated a rolling submission of its Biologics License Application (BLA) to the FDA for MCO-010, a first-in-class, gene-agnostic optogenetic therapy targeting severe vision loss due to retinitis p...

Jun 24, 2025

Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma; Gilead’s YEZTUGO Becomes First FDA-Approved HIV Prevention with 6-Month Protection; FDA Reviewing Incyte’s OPZELURA for Pediatric Atopic Dermatitis (Ages 2–11); Archeus Technologies Receives FDA Clearance for Prostate Cancer Therapy ART-101; Cycle Pharmaceuticals’ HARLIKU Gets First FDA Approval for Alkaptonuria

Incyte’s MONJUVI Combo Approved by FDA for Relapsed/Refractory Follicular Lymphoma Incyte has announced that the FDA has approved MONJUVI (tafasitamab-cxix) in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). This makes it the f...

Nov 05, 2024

Prolong’s PP-007 Fast-Tracked for Stroke; FDA Expands JYLAMVO Pediatric Approval; Corcept’s Cushing’s Drug Shows Positive Phase III Results; ESSA Halts Phase II Study of Masofaniten for Prostate Cancer; SCEMBLIX Approved for Leukemia

Prolong Pharmaceuticals Secures FDA Fast Track for PP-007 in Stroke Therapy Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, announced that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has been granted Fast Track designation by the FDA for the treatment of a...

pharma-news-for-boehringer-ingelheim-novartis-astellas-pfizer

May 07, 2024

Boehringer Ingelheim’s Diabetic Macular Ischemia Study; Novartis’ Mariana Oncology Acquisition; Astellas and Poseida Therapeutics Partnership; Prime Medicine’s PM359 IND; Pfizer’s TIVDAK FDA Approval

Boehringer Ingelheim Announces Promising Findings From Groundbreaking Study on Diabetic Macular Ischemia Boehringer Ingelheim released encouraging results from the HORNBILL Phase I/IIa trial of BI 764524, marking the pioneering investigation into a potential therapy for individuals with diabetic macular is...

Pharma News for GSK, Roche, Eli Lilly, Coherus

Oct 31, 2023

Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC

FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...

Pharma News for XORTX, Roche, Lantheus, Janssen, Daiichi Sankyo, bluebird bio, and POINT Biopharma Global

Apr 25, 2023

Janssen’s AKEEGA Approval; FDA Approves Roche’s Polivy Combo for Frontline B-cell Lymphoma; Daiichi Sankyo’s Quizartinib for Adults With FLT3-ITD-Positive AML; bluebird bio BLA for lovo-cel for Patients with Sickle Cell Disease; Fast Track Designation for Lu-PNT2002 for mCRPC Treatment; FDA Orphan Drug Designation to XORTX’s Oxypurinol

Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) had granted marketing authorization for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form...

pharma-news-for-accutar-bio-thera-nykode-heat-biologics-elusys

Jan 04, 2022

Accutar’s Phase I clinical trial for AC0176; Bio-Thera’s cancer drug, BAT6005; Nykode’s Covid-19 vaccine trial; Heat Biologics acquires Elusys

FDA approves IND application of Accutar for a prostate cancer treatment trial The US Food and Drug Administration (FDA) has granted Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating metastatic castration-resistant prostate cancer (mCRPC). An i...

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metastatic castration-resistant prostate cancer

Prolong’s PP-007 Fast-Tracked for Stroke; FDA Expands JYLAMVO Pediatric Approval; Corcept’s Cushing’s Drug Shows Positive Phase III Results; ESSA Halts Phase II Study of Masofaniten for Prostate Cancer; SCEMBLIX Approved for Leukemia

Boehringer Ingelheim’s Diabetic Macular Ischemia Study; Novartis’ Mariana Oncology Acquisition; Astellas and Poseida Therapeutics Partnership; Prime Medicine’s PM359 IND; Pfizer’s TIVDAK FDA Approval

Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC

Accutar’s Phase I clinical trial for AC0176; Bio-Thera’s cancer drug, BAT6005; Nykode’s Covid-19 vaccine trial; Heat Biologics acquires Elusys

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