SOFIE Biosciences doses first patient in Phase III FAPI-PRO trial for pancreatic cancer imaging
SOFIE Biosciences has dosed the first patient in its Phase III FAPI-PRO trial evaluating 18F-FAPI-74 PET/CT for detecting metastatic pancreatic ductal adenocarcinoma, with 18 sites planned across 24 months.
Clinical Trials | 13/02/2026 | By News Bureau
FibroBiologics Files IND Application with US FDA for CYPS317 in Psoriasis
FibroBiologics has filed an Investigational New Drug (IND) application with the US FDA for CYPS317, marking a key step towards initiating clinical development of the therapy for psoriasis, supported by encouraging preclinical data showing reduced disease severity and relapse.
Clinical Trials | 03/01/2026 | By News Bureau
PharmAla Biotech Australia Ties Up with UK CDMO to Manufacture ALA-002
PharmAla Biotech Australia has contracted a UK-based CDMO to manufacture the drug substance for ALA-002, its patented non-racemic MDMA formulation, ahead of planned phase 2a/2b clinical trials for social anxiety disorder expected to begin in 2026.
Clinical Trials | 16/12/2025 | By News Bureau
AstraZeneca Plans USD 2 Billion Manufacturing Investment in Maryland
AstraZeneca will invest USD 2 billion to expand its biologics manufacturing in Maryland, boosting production of cancer, rare disease, and chronic therapies while supporting around 2,600 jobs.
Clinical Trials | 24/11/2025 | By Dineshwori | 109
UK Halves Clinical Trial Approval Times Through Major Digital Reforms
Backed by major reforms and new digital platforms at the Medicines and Healthcare products Regulatory Agency (MHRA), the UK has reduced the average clinical trial approval time by more than half — from 91 days to just 41 days.
Clinical Trials | 08/10/2025 | By Dineshwori | 229
WHO launches Global Clinical Trials Forum
The Forum responds to World Health Assembly resolution WHA75.8, which called on WHO to improve the quality and coordination of clinical trials to generate high-quality evidence for health decision-making.
Clinical Trials | 08/10/2025 | By Dineshwori | 151
Amgen Partners with Veeva Systems to Drive Innovation in Clinical Trials
Veeva Systems, a leading provider of cloud-based software, data, and consulting services for the life sciences industry, has announced a strategic collaboration with biotechnology giant Amgen to advance clinical trial innovation.
Clinical Trials | 01/09/2025 | By Darshana | 223
CDSCO Mandates Online Submission of CGTP Clinical Trial Applications via SUGAM Portal
For now on, offline submissions of clinical trial applications for Cell and Gene Therapy Products (CGTPs) will not be accepted by the CDSCO.
Clinical Trials | 11/07/2025 | By Dineshwori | 288
DHL Group Acquires CRYOPDP from Cryoport to Boost DHL Health Logistics
Going forward, DHL Supply Chain will further build the potential of its Pharma Specialized Network solution by leveraging the specialty courier expertise of newly acquired CRYOPDP and the global air capabilities of DHL Express and DHL Global Forwarding.
Clinical Trials | 05/04/2025 | By Aishwarya | 263
Chance Pharma Receives New Funding to Develop Innovative Inhalation Therapies
Chance Pharma operates state-of-the-art production facilities compliant with FDA and EMA quality standards, underscoring its strong capabilities in both R&D and manufacturing.
Clinical Trials | 18/03/2025 | By Aishwarya | 181
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