News
The most recent news and industry headlines are presented in this section. Our dedicated team closely observes the pharmaceutical industry and keeps you informed of the most recent developments around the Europe.
Allogene Therapeutics Gains FDA RMAT and Fast Track Status for Cema-Cel in First-Line Large B-Cell Lymphoma
Thursday, July 30, 2026Allogene Therapeutics has received Regenerative Medicine Advanced Therapy RMAT and Fast Track designations from the US Food and Drug Administration FDA for its investigational allogeneic CAR T therapy
Ocugen Receives FDA RMAT Designation for OCU410 in Geographic Atrophy
Thursday, July 30, 2026Ocugen has received Regenerative Medicine Advanced Therapy RMAT designation from the US Food and Drug Administration FDA for its investigational gene therapy OCU for the treatment of geographic atrophy
Eton Pharmaceuticals Seeks FDA Approval to Expand KHINDIVI Use in Younger Children
Thursday, July 30, 2026Eton Pharmaceuticals has submitted a Prior Approval Supplement PAS to the US Food and Drug Administration FDA seeking to expand the approved use of KHINDIVI hydrocortisone oral solution
Dyne Therapeutics Receives FDA Clearance to Begin Phase 1 Trial of DYNE-302 for FSHD
Wednesday, July 29, 2026Dyne Therapeutics has received clearance from the US Food and Drug Administration FDA for its Investigational New Drug IND application to begin a Phase clinical trial of DYNE for the treatment of facioscapulohumeral
Antag Therapeutics Doses First Patient in Phase 2a Trial of AT7687 for Obesity and Type 2 Diabetes
Wednesday, July 29, 2026Antag Therapeutics has dosed the first participant in its Phase a clinical trial evaluating AT a firstinclass glucosedependent insulinotropic polypeptide receptor GIPR antagonist in combination
HAYA Therapeutics Receives FDA Fast Track Designation for HTX-001 in Non-Obstructive Hypertrophic Cardiomyopathy
Wednesday, July 29, 2026HAYA Therapeutics has received Fast Track designation from the US Food and Drug Administration FDA for HTX its investigational therapy for the treatment of symptomatic nonobstructive hypertrophic cardiomyopathy nHCM
Eikon Therapeutics Doses First Patient in Phase 2/3 NSCLC Trial of EIK1001
Tuesday, July 28, 2026Eikon Therapeutics has dosed the first patient in the TeLuRide Phase registrational trial which is evaluating EIK in combination with pembrolizumab and histologyspecific chemotherapy as a firstline treatment
CAMP4 Therapeutics Receives Australian Clearance to Begin First-in-Human Trial of CMP-002 for SYNGAP1-Related Disorder
Tuesday, July 28, 2026CAMP Therapeutics has received regulatory clearance from Australias Therapeutic Goods Administration TGA and approval from a local Human Research Ethics Committee HREC to begin its Phase clinical trial of CMP an investigational treatment for SYNGAPr...
IDEAYA begins Phase 1/2 expansion study of IDE892 in MTAP-deleted pancreatic and lung cancers
Monday, July 27, 2026IDEAYA Biosciences has initiated Part of the Phase clinical trial evaluating IDE its investigational methylthioadenosine MTAcooperative PRMT inhibitor as a monotherapy for patients with MTAP
Ipsen Reports Phase III BOLD Trial Results in Biliary Atresia
Friday, July 24, 2026Ipsen has announced that its Phase III BOLD trial evaluating Bylvay odevixibat in patients with biliary atresia BA who had previously undergone Kasai hepatoportoenterostomy HPE did not meet its primary endpoint of improving native liver survival comp...
