BioReview - BioReview (Page 7)

Biotechnology

Ultragenyx's $1 Billion Wipeout Exposes the Harsh Realities of Rare Disease Drug Development

The final days of 2025 delivered a devastating blow to Ultragenyx Pharmaceutical as the company lost over $1 billion in market value following the failure of its bone disease therapy setrusumab in two pivotal Phase III trials. The December 29 announcement that the drug failed to reduce fracture rates in

Pharmaceuticals

Vanda Pharmaceuticals Surges on VVX-001 Breakthrough Designation and European Partnership

Vanda Pharmaceuticals surged 25.46% following FDA's Breakthrough Therapy Designation for VVX-001 and a strategic European partnership, signaling major progress in psychedelic-assisted therapy for treatment-resistant depression.

Biotechnology

AbbVie's $1.2 Billion Zelgen Deal Signals Major Push Into T-Cell Engager Market

AbbVie kicked off 2026 with a strategic bang, announcing a potentially $1.2 billion licensing deal with China's Suzhou Zelgen Biopharmaceuticals for exclusive rights to develop and commercialize alveltamig (ZG-006) outside of Greater China. The New Year's Eve agreement represents one of the largest T-cell engager

Pharmaceuticals

Year-End FDA Rejections Deliver Harsh Reality Check to Sanofi and Corcept

The final days of 2025 delivered unwelcome surprises to two pharmaceutical companies as the FDA issued complete response letters rejecting drug applications from both Sanofi and Corcept Therapeutics. These unexpected regulatory setbacks underscore the unpredictable nature of drug approval processes and highlight how even promising therapies with strong clinical data

Biotechnology

FibroBiologics Pioneers Novel Fibroblast Spheroid Therapy for Psoriasis with FDA Filing

FibroBiologics files IND application for CYPS317, marking the first fibroblast spheroid-based therapy to enter clinical development for psoriasis, with compelling preclinical data showing superior durability compared to existing biologic treatments.

Vanda Pharmaceuticals Breaks 40 Year Motion Sickness Drug Drought With FDA Approval

Vanda Pharma achieved a historic milestone with FDA approval of NEREUS (tradipitant) for motion sickness prevention, the first new treatment in 40 years.

Zoliflodacin Breakthrough: Single-Dose Pill Tackles Antibiotic-Resistant Gonorrhea

A groundbreaking phase 3 clinical trial published in The Lancet has demonstrated that zoliflodacin, a single-dose oral antibiotic, matches the effectiveness of current standard treatments for gonorrhea while offering significant advantages in simplicity and accessibility. This development represents a critical breakthrough in the ongoing battle against antibiotic-resistant sexually transmitted infections,

Neuralink's Production Scale-Up Marks Neurotechnology's Commercial Turning Point

Neuralink's announcement to scale up brain-computer interface production in 2026 signals a potential inflection point for the neurotechnology sector, with implications for accessibility and cost reduction.