SpringWorks Wins EU Nod for EZMEKLY® in NF1-Related Tumours

SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced  that the European Commission (EC) granted conditi...

July 21, 2025 | Monday | News
Johnson & Johnson’s TAR-200 Receives FDA Priority Review for BCG-Unresponsive Bladder Cancer

New Drug Application supported by results from the Phase 2b SunRISe-1 study Johnson & Johnson announced that the U.S. Food and Drug Administration (...

July 18, 2025 | Friday | News
Ultragenyx Receives Complete Response Letter from FDA for UX111 Gene Therapy for Sanfilippo Syndrome Type A

Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its Biologics L...

July 14, 2025 | Monday | News
CARsgen Secures Final EPO Win for GPC3 CAR-T Patent After Appeal Withdrawal

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces a favorable outco...

July 14, 2025 | Monday | News
Trethera’s TRE-515 Receives FDA Fast Track Designation for Advanced Prostate Cancer Treatment

Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune d...

July 11, 2025 | Friday | News
Ascentage Pharma Secures China’s First Approval for Bcl-2 Inhibitor in CLL/SLL with Lisaftoclax

Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, announced that it...

July 11, 2025 | Friday | News
Zhimeng Biopharma Receives CDE Approval to Advance CB03-154 into Phase 2/3 Trials for ALS in China

Shanghai Zhimeng Biopharma, Inc. ("Zhimeng Biopharma"), a clinical-stage biopharmaceutical company dedicated to innovative drug development for liver and...

July 10, 2025 | Thursday | News
Esperion Reaches Patent Settlement with Accord Healthcare Over Generic NEXLETOL

Esperion announced that it has entered into a settlement agreement with Accord Healthcare Inc. This agreement resolves the patent litigation brought by E...

July 09, 2025 | Wednesday | News
Johnson & Johnson Submits EMA Application to Broaden AKEEGA® Use in HRR‑Mutated Metastatic Hormone‑Sensitive Prostate Cancer

The submission is based on results from the Phase 3 AMPLITUDE study evaluating niraparib in combination with abiraterone acetate plus prednisone or predn...

July 07, 2025 | Monday | News
Masitinib Receives FDA and EMA Authorisation for Confirmatory Phase 3 Trial in Metastatic Castrate-Resistant Prostate Cancer

MASITINIB RECEIVES FDA AND EMA AUTHORIZATION FOR CONFIRMATORY PHASE 3 TRIAL IN METASTATIC CASTRATE-RESISTANT PROSTATE CANCER, WITH BIOMARKER-DRIVEN PATIE...

July 07, 2025 | Monday | News
JCR Pharmaceuticals Completes Enrollment in Global Phase III Trial of JR-141 for Hunter Syndrome Across the U.S., Latin America, and Europe

-JCR Pharmaceuticals Co., Ltd. (TSE 4552; JCR) announced that it achieved the enrollment of the target number of participants in the global Phase III cli...

July 03, 2025 | Thursday | News
Carthera’s SonoCloud® Wins EMA Endorsement as Orphan Medical Device for Recurrent Glioblastoma

Carthera, a spin-off from Sorbonne University founded by Pr. Alexandre Carpentier, and developer of SonoCloud®, an innovative ultrasound-based med...

July 02, 2025 | Wednesday | News
HUTCHMED and AstraZeneca Secure China Approval for ORPATHYS®–TAGRISSO® Combination in EGFR-Mutant NSCLC with MET Amplification

HUTCHMED (China) Limited  announces that the New Drug Application (“NDA”) for the combination of ORPATHYS® (savolitinib) and TAGRISS...

July 01, 2025 | Tuesday | News
Sanofi’s Riliprubart Secures FDA Orphan Drug Status for AMR in Transplants; Phase 2 Kidney Study Underway

Ongoing phase 2 study evaluating riliprubart for the potential prevention and treatment of active antibody-mediated rejection in kidney transplant reci...

June 25, 2025 | Wednesday | News

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