Regulatory Pathway– tag –
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Eli Lilly Acquires AtaiBeckley to Accelerate Phase III Development of BPL-003 for Treatment-Resistant Depression and Mental Health
Eli Lilly and Company USA Overview Eli Lilly announced the acquisition of AtaiBeckley to accelerate the development of therapies for treatment-resistant depression (TRD) and other mental health conditions. AtaiBeckley's lead candidate, B... -
How Gene Therapies Get to Patients Faster: Liv Hospital Explores FDA’s Expedited Pathways
Liv Hospital Turkey Overview Liv Hospital has published a comprehensive article clarifying the U.S. FDA's expedited approval pathways for gene therapies, focusing on Breakthrough Therapy Designation and Accelerated Approval. These crucia... -
FDA Seeks Input on Psychedelic Drug Therapeutic Use: Exploring Psilocybin and MDMA for Depression and PTSD
RAPS USA Overview The U.S. FDA is soliciting public input on the potential therapeutic uses of psychedelic drugs, specifically psilocybin for depression and MDMA-assisted therapy for PTSD. While the FDA granted Breakthrough Therapy Desig... -
EMD Serono’s Investigational Enpatoran Granted FDA Breakthrough Therapy Designation for Active Cutaneous Lupus
Lupus Foundation of America USA Overview EMD Serono's investigational drug enpatoran has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of systemic lupus erythematosus (SLE) with active cutaneous manifestat... -
NIH’s NCATS Secures FDA IND Clearance for Gene Therapy Targeting Ultra-Rare Multiple Sulfatase Deficiency
National Center for Advancing Translational Sciences - NIH USA Overview The National Center for Advancing Translational Sciences (NCATS), part of the NIH, announced FDA clearance of an Investigational New Drug (IND) application for a gen... -
FDA Grants Fast Track Designation to Multiple Oncology Drugs in May & June 2026, Including ADC for Metastatic Neuroendocrine Tumors
Oncology News Central USA Overview In May and June 2026, the U.S. FDA granted Fast Track designation to several novel oncology therapies, accelerating their development for serious conditions. Noteworthy designations include Zai Lab Limi... -
Exponential Progression of Targeted Protein Degradation: First FDA-Approved PROTAC and Molecular Glues Unlock “Undruggable” Targets
MarinBio (Appears to be a scientific review/journal, affiliated with MarinBio, hence using their domain) USA Overview The field of targeted protein degradation (TPD) is rapidly evolving, enabling the degradation of previously "undruggabl... -
Helus Pharma™’s Breakthrough-Designated Depression Drug HLP003 Completes 86% Enrollment in Phase 3 Trial, Topline Data Expected Q4 2026
PR Newswire Unknown Overview Helus Pharma™’s APPROACH Phase 3 trial for HLP003, an investigational adjunct therapy for major depressive disorder (MDD), has successfully completed over 86% of patient enrollment. HLP003 has received Breakt... -
Kowa’s Selective PPARα Modulator Pemafibrate Receives FDA Breakthrough Therapy Designation for Primary Biliary Cholangitis Treatment, Demonstrating Significant ALP Improvement in Phase II Data
Morningstar Japan Overview Japan's Kowa Company has announced that its selective PPARα modulator "K-808" (pemafibrate) has been granted Breakthrough Therapy designation by the U.S. FDA for the treatment of primary biliary cholangitis (PB... -
MAIA Biotechnology Completes Global Enrollment for Phase 2 Ateganosine Trial in Refractory NSCLC
GlobeNewswire USA Overview MAIA Biotechnology has completed global enrollment for Part C of its Phase 2 THIO-101 expanded trial, evaluating ateganosine for third-line advanced non-small cell lung cancer (NSCLC). Ateganosine, an investiga...
