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
Bristol Myers Squibb’s streamlined CAR T therapy labels signal broader patient access and regulatory confidence

Bristol Myers Squibb’s announcement that the US Food and Drug Administration has approved the removal of REMS programs an...

June 27, 2025 | Friday | 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
Novadip Biosciences Secures FDA RMAT Designation for NVD003 in Rare Pediatric Bone Disorder

Novadip Biosciences, a late-stage clinical biotechnology company specializing in regenerative medicine, announces that the FDA has granted the Regenerative...

June 24, 2025 | Tuesday | 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
Nutriband and Kindeva Complete Commercial Manufacturing Scale-Up for AVERSA™ Fentanyl, Advancing World’s First Abuse-Deterrent Opioid Patch

Nutriband Inc.  a company engaged in the development of prescription transdermal pharmaceutical products, announced that it has completed commercial...

June 24, 2025 | Tuesday | News
Perceptive Discovery Launches FIBRE Consortium with Pfizer, Lantheus, and Lumina to Advance Imaging Biomarkers in Fibrotic Diseases

Perceptive Discovery, a global leader in molecular and functional imaging research, today announced the launch of the FIBRE (Fibrosis Imaging Biomarker R...

June 23, 2025 | Monday | News
Lilly’s Once-Weekly Efsitora Matches Daily Insulin in Phase 3 Trials, Global Filing Planned by Year-End

Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with...

June 23, 2025 | Monday | Reports

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