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FDA Grants Orphan Drug Status to BlueRock's OpCT-001
The ODD supports the clinical development of OpCT-001, the first iPSC-derived investigational cell therapy to enter human trials for Retinitis Pigmentosa (RP), a common inherited retinal disease marked by progressive loss of photoreceptor cells.
USFDA | 23/01/2026 | By News Bureau
ImmunityBio Advances FDA Talks on ANKTIVA Resubmission
ImmunityBio said the FDA has requested additional information to potentially support a resubmission of the sBLA for ANKTIVA in BCG-unresponsive papillary bladder cancer, without requiring new clinical trials, with the company planning to submit the data within 30 days.
USFDA | 21/01/2026 | By News Bureau
FDA Grants Orphan Drug Designation to LP-284 of Lantern Pharma
The designation marks the third FDA orphan status for LP-284 and the sixth across Lantern Pharma’s AI-driven oncology pipeline, strengthening the programme’s development momentum in soft tissue sarcomas, a rare cancer segment with significant unmet need and a growing global market.
USFDA | 21/01/2026 | By News Bureau
FDA Acknowledges Pain Reduction Data Supporting Rexlemestrocel-L Efficacy
The US Food and Drug Administration (FDA) has acknowledged clinical data showing that Rexlemestrocel-L reduced pain intensity over 12 months, supporting the product’s efficacy in treating back pain. The agency also indicated that the approval label may include language related to opioid reduction.
USFDA | 19/01/2026 | By News Bureau
Dr Reddy's Launches First-to-Market Olopatadine Ophthalmic Solution in US
With the US launch of its first-to-market OTC Olopatadine 0.7 percent eye drops, Dr Reddy’s expands access to allergy relief for itchy eyes caused by pollen and other common allergens.
USFDA | 15/01/2026 | By News Bureau
FDA Publishes Guidance on Modern Statistical Methods for Clinical Research
The FDA guidance provides a framework for applying Bayesian analyses in clinical research, enabling data-driven assessments of safety and efficacy using both current and prior evidence.
USFDA | 14/01/2026 | By News Bureau
Japan Approves Exdensur for Severe Asthma and Nasal Polyps
Japan has approved Exdensur (depemokimab) for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), marking the first ultra-long-acting biologic in the country, with approval supported by phase-III SWIFT and ANCHOR trial data demonstrating sustained efficacy with twice-yearly dosing.
USFDA | 07/01/2026 | By News Bureau | 157
Axsome Therapeutics’ investigational oral drug AXS-05 is advancing clinical development for Alzheimer’s disease agitation and smoking cessation, leveraging a unique multimodal mechanism targeting key neurotransmitter pathways.
USFDA | 03/01/2026 | 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.
USFDA | 03/01/2026 | By News Bureau
FDA Accepts for Review INOVIO BLA for INO-3107 in RRP
The US FDA has accepted for review INOVIO’s Biologics Licence Application (BLA) for INO-3107 for the treatment of adults with Recurrent Respiratory Apillomatosis (RRA), assigning a PDUFA action date of 30 October, 2026, and indicating that it does not currently plan to convene an advisory committee meeting for the application.
USFDA | 31/12/2025 | By News Bureau
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