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
Alvotech and Advanz Pharma Receive CHMP Positive Opinion for AVT06, a Proposed Biosimilar to Eylea®

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Adva...

June 24, 2025 | Tuesday | News
Ipsen’s Cabometyx® Receives Positive CHMP Opinion for Advanced Neuroendocrine Tumors

Ipsen  announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion...

June 23, 2025 | Monday | News
Bayer Submits US FDA Application for Gadoquatrane, a Low-Dose MRI Contrast Agent

FDA submission seeks approval for investigational gadolinium-based contrast agent (GBCA) gadoquatrane for contrast-enhanced magnetic resonance imagin...

June 18, 2025 | Wednesday | News
Sarepta Halts ELEVIDYS Shipments for Non-Ambulatory Duchenne Patients After Second Fatal Case of Acute Liver Failure

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today provided a safety update regarding ELEVIDYS (...

June 16, 2025 | Monday | News
EMA Committee Backs Merck Animal Health’s NUMELVI as First Second-Generation JAK Inhibitor for Canine Allergic Dermatitis

If Approved, NUMELVI Will Be the First and Only Second-Generation Janus Kinase (JAK) Inhibitor for the Treatment of Pruritus Associated with Allergic D...

June 13, 2025 | Friday | News

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