Pharmaceuticals

Biotechnology

Pentixapharm Breaks New Ground: FDA Clears Revolutionary CXCR4-Targeted Theranostic Program for Blood Cancer Treatment

Berlin-based Pentixapharm announces FDA clearance of two Investigational New Drug applications for its groundbreaking CXCR4-targeted theranostic program combining precision imaging with targeted radiotherapy for blood cancer treatment.

Biotechnology

Gilead's $7.8 Billion Gamble: Why the Arcellx Acquisition Could Reshape Multiple Myeloma Treatment

Gilead Sciences' $7.8 billion acquisition of Arcellx marks a strategic bet on anito-cel, a promising CAR-T therapy that could transform multiple myeloma treatment and revitalize the company's cell therapy business.

Policy

FDA Drops Two-Trial Dogma: Historic Policy Shift Could Accelerate Drug Approvals and Transform Biotech Development

In what may be the most significant regulatory development for biotech in a decade, the FDA announced on February 18, 2026, that it is abandoning its long-standing expectation of two pivotal clinical trials for new drug approvals. Moving forward, the agency will require only one adequate and well-controlled

Biotechnology

Genentech Achieves Major Regulatory Milestone as FDA Accepts Giredestrant Application for Advanced Breast Cancer

Genentech announces FDA acceptance of New Drug Application for giredestrant, an oral selective estrogen receptor degrader combination therapy for ESR1-mutated advanced breast cancer, with priority review and December 2026 decision target.

Pharmaceuticals

Johnson & Johnson Achieves FDA Breakthrough: Rybrevant Faspro Expands Beyond Lung Cancer Into Head and Neck Malignancies

In a significant regulatory milestone that could transform treatment options for one of oncology's most challenging malignancies, Johnson & Johnson announced on February 18, 2026, that the FDA has granted Breakthrough Therapy Designation to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for treating advanced head and neck squamous cell

Pharmaceuticals

Novartis Achieves Historic Breakthrough: Remibrutinib Becomes First Targeted Therapy to Succeed in Chronic Inducible Urticaria Phase III Trial

Novartis announces positive Phase III results for remibrutinib in chronic inducible urticaria, positioning the oral BTK inhibitor as the first targeted therapy for this debilitating condition affecting millions worldwide.

Biotechnology

Krystal Biotech Achieves Historic FDA Breakthrough: First Inhalable Gene Therapy for Lung Cancer Receives RMAT Designation

Krystal Biotech announces FDA RMAT designation for KB707, the world's first inhalable gene therapy for advanced lung cancer, marking a revolutionary breakthrough in cancer treatment.

Pharmaceuticals

FDA's Unprecedented Rejection of Moderna's mRNA Flu Vaccine Sends Shockwaves Through Biotech Industry

The FDA's unprecedented rejection of Moderna's mRNA flu vaccine application marks a dramatic departure from traditional regulatory practices and raises profound questions about the future of vaccine innovation in America.

Biotechnology

HanchorBio Achieves FDA Breakthrough: First SIRPα-IgG4 Fc Fusion Protein Granted Orphan Status for Gastric Cancer

Taiwan-based HanchorBio announced FDA Orphan Drug Designation for HCB101, marking the first recognition of a SIRPα-IgG4 Fc fusion protein in gastric cancer treatment.

Pharmaceuticals

Roche's Fenebrutinib Emerges as Potential Breakthrough in Primary Progressive Multiple Sclerosis

In a landmark development that could transform treatment for one of neurology's most challenging conditions, Swiss pharmaceutical giant Roche has unveiled late-breaking Phase III data showing its investigational oral therapy fenebrutinib significantly slowed disability progression in people with primary progressive multiple sclerosis (PPMS). The results position fenebrutinib

Biotechnology

Eli Lilly Makes Bold $2.4 Billion Bet on Revolutionary In Vivo CAR-T Technology with Orna Therapeutics Acquisition

Eli Lilly's $2.4 billion acquisition of Orna Therapeutics marks a transformative entry into in vivo CAR-T therapy, leveraging revolutionary circular RNA technology to democratize cell therapy for autoimmune diseases.

Biotechnology

REGENXBIO Faces Critical Setback as FDA Halts Gene Therapy Trials Following Pediatric Brain Tumor Discovery

REGENXBIO announced that the FDA has placed clinical holds on RGX-111 and RGX-121 following the discovery of a brain tumor in a pediatric patient treated with gene therapy, raising critical questions about AAV vector safety.