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
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
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
Amarna Therapeutics and NorthX Biologics Advance Gene Therapy Manufacturing for Type 1 Diabetes

Amarna Therapeutics, (“Amarna” or “the Company”), a privately held biotechnology company pioneering transformative gene therapies...

July 09, 2025 | Wednesday | News
Certara Expands Partnership with Merck to Advance Metadata and Data Standards Management

Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced a new collaboration with Merck, known as MSD outside of...

July 09, 2025 | Wednesday | News
Conduit Pharmaceuticals Expands IP Portfolio with Four New Patent Filings for AZD1656 and AZD5658

Conduit Pharmaceuticals Inc.  announces the filing of four new patent applications relating to its key assets AZD1656 and AZD5658, including the Com...

July 08, 2025 | Tuesday | News
Synfini Secures $8.9M to Accelerate AI-Driven Chemistry Automation, Bringing Total Funding to $53M

Synfini, Inc., a trailblazer in AI-driven chemistry automation, today announced a $8.9 million expansion of its round, led by JSL Health Capital and supp...

July 08, 2025 | Tuesday | News
Oxford BioTherapeutics Achieves Milestone as Boehringer Ingelheim Selects Third Cancer Drug Candidate for IND-Enabling Studies

Drug candidate is one of several oncology assets approaching or in clinical development, discovered through Oxford BioTherapeutics’ proprietary OGA...

July 07, 2025 | Monday | 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
Nxera Pharma to Receive US$4.8 Million in Milestone Payments as Centessa Advances Orexin Agonist into Clinical Development

Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) today announces that it will receive US$4.8 million in milestone paym...

July 07, 2025 | Monday | News
Axplora Launches €35 Million Farmabios Expansion to Reinforce API Manufacturing Leadership in Italy

Axplora is proud to unveil a transformative €35 million expansion at its Farmabios site  in Gropello Cairoli, Italy, reinforcing the company&rsqu...

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
Singapore’s Gero Launches ProtoBind-Diff, a Sequence-Only AI Model Generating Drug-Like Molecules Without 3D Structures

ProtoBind-Diff generates drug-like molecules for specific protein targets using only their amino acid sequences—no 3D structures required. The m...

June 30, 2025 | Monday | News

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