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.
FDA Grants Orphan Drug Designation to Enzomenib for Acute Lymphoblastic Leukaemia
Friday, July 31, 2026Sumitomo Pharma America has announced that the US Food and Drug Administration FDA has granted Orphan Drug Designation to enzomenib DSP for the treatment of patients with acute lymphoblastic leukaemia ALL
Iksuda Receives FDA Clearance to Begin Phase I Trial of IKS04
Friday, July 31, 2026Iksuda Therapeutics has received Investigational New Drug IND clearance from the US Food and Drug Administration FDA for IKS allowing the company to begin a Phase I clinical trial in patients with gastrointestinal GI cancers
Abivax Advances NDA Plans for Obefazimod Following Positive FDA Meeting
Friday, July 31, 2026Abivax has completed a positive preNew Drug Application NDA meeting with the US Food and Drug Administration FDA for obefazimod its investigational treatment for adults with moderately to severely active ulcerative colitis UC
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
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
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
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
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
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
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...
