ABLi Therapeutics Announces Publication of the Final Results from the Phase 2 ‘201 Trial’ Evaluating Risvodetinib for the Treatment of Parkinson’s Disease

ABLi Therapeutics (“ABLi”), a biotechnology company developing therapeutics to address diseases that arise from activation of Abelson Tyrosine Kinases (c-Abl kinases), announces publication of the ...
CURE

Genetic Discovery Explains Drug Resistance in Breast Cancer

Resistant cells demonstrated global decreases in DNA accessibility with localized opening at resistance-driving loci, indicating non-mutational epigenetic reprogramming rather than canonical oncogenic ...
PharmiWeb

RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Breakthrough Therapy Designation for patients with advanced head and neck cancer

Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for subcutaneous amivantamab and hyaluronidase-lpuj as ...
PharmiWeb

Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL

Regulatory submission is based on positive results from the Phase 2 PROSPECT Study —– FDA sets PDUFA Date of December 18, 2026 —OSAKA, Japan & WALTHAM, Mass.--(BUSINESS WIRE)--Deciphera ...
Le Lézard

FDA approves RYBREVANT FASPROtm (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved a new, simplified monthly dosing schedule* for RYBREVANT FASPROtm (amivantamab and hyaluronidase-lpuj). When ...
Targeted Oncology

FDA Accepts New Drug Application for BTK Inhibitor Tirabrutinib

The FDA has accepted the new drug application (NDA) for tirabrutinib (ONO-4059), a highly selective, irreversible, second-generation Bruton tyrosine kinase (BTK) inhibitor developed for the treatment ...

Johnson & Johnson: FDA approves RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

Monthly dosing reduces treatment visits while maintaining established safety and efficacy1,2 Builds on RYBREVANT FASPRO FDA approval to deliver the simplest and fastest ...