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CTx001, an AAV-based gene therapy, delivers a mini-CR1 protein to modulate complement pathways and address Geographic Atrophy (GA), an advanced dry AMD causing irreversible vision loss.
US FDA | 09/10/2025 | By Dineshwori
Merck Completes Acquisition of Verona Pharma
The acquisition of Verona Pharma strengthens Merck’s cardio-pulmonary portfolio with addition of Ohtuvayre (ensifentrine), a first-in-class COPD maintenance treatment, that is expected to grow into the next decade.
US FDA | 08/10/2025 | By Dineshwori
Concept Life Sciences Unveils Major Expansion of UK Drug Discovery Facilities
Concept Life Sciences, a multi-disciplined contract research organisation, has officially opened its newly expanded integrated drug discovery facilities at its Chapel-en-le-Frith headquarters, establishing one of the UK’s largest drug discovery research sites.
US FDA | 30/09/2025 | By Darshana
US FDA Declines Approval for Biogen's Higher-Dose Spinraza in SMA
The decision was relayed via a ‘complete response letter’ to Biogen, which clarified there were no issues with the clinical data behind the new high-dose regimen. Biogen says it will resubmit the application promptly, drawing on information that is already at hand.
US FDA | 24/09/2025 | By Darshana
GSK to submit label update for Wellcovorin at US FDA's request
GSK will file an sNDA with the US FDA to update Wellcovorin’s label to include Cerebral Folate Deficiency, following the agency’s request under its initiative to repurpose older drugs for chronic conditions.
US FDA | 24/09/2025 | By Dineshwori
US FDA Grants Fast Track Designation to AAV Gene Therapy by Sanofi
The US FDA has granted fast track designation to Sanofi’s SAR446268, an AAV gene therapy for juvenile and adult-onset myotonic dystrophy type 1 (DM1).
US FDA | 23/09/2025 | By Dineshwori
USFDA Completes Inspection of Indoco API Plant in Patalganga with Zero Observations
The inspection of Indoco’s API manufacturing facility at Patalganga by the US FDA concluded with zero form 483 observations.
US FDA | 22/09/2025 | By Dineshwori
FDA Grants BTD to Raludotatug Deruxtecan for Platinum-Resistant Ovarian Cancer
This is the first BTD granted for Raludotatug Deruxtecan, the second for the Daiichi Sankyo-Merck partnership and the 15th across Daiichi Sankyo’s oncology portfolio, marking a significant milestone in the companies’ joint efforts to develop innovative cancer therapies.
US FDA | 16/09/2025 | By Dineshwori
NMPA Clears Zhimeng Biopharma's Drug for Phase-II Epilepsy Trial
Zhimeng Biopharma’s drug for Phase II epilepsy trial will be evaluated in a randomized, double-blind, placebo-controlled multinational study to test its efficacy, safety, and tolerability as an adjunct therapy in adults with focal epilepsy.
US FDA | 13/09/2025 | By Dineshwori
Sanofi Drug Earns Fast Track Status for Wet AMD in US
Sanofi is evaluating SAR402663 in a Phase 1/2 trial (NCT06660667) for neovascular AMD. The gene therapy targets abnormal blood vessel growth, reduces retinal damage, and aims to eliminate the need for frequent intravitreal injections.
US FDA | 11/09/2025 | By Dineshwori
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