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News about "US FDA "
Aurobindo Pharma's API Facility Receives Zero Observations in US FDA Inspection
Aurobindo Pharma said the US FDA inspection of its API manufacturing facility in Pydibhimavaram, Andhra Pradesh, concluded with zero observations.
US FDA | 15/09/2026 | By News Bureau
Alebund Receives US FDA IND Clearance for IgA Nephropathy Drug Candidate AP308
Alebund Pharmaceuticals has received US FDA IND clearance for AP308, an engineered recombinant IgA protease, paving the way for first-in-human clinical testing in IgA nephropathy.
US FDA | 10/09/2026 | By News Bureau
Indoco Remedies Receives Seven Form 483 Observations Following US FDA Inspection
Indoco Remedies’ Plant 2 (Sterile) facility in Goa received seven Form 483 observations following a USFDA inspection conducted from August 27 to September 4, 2026.
US FDA | 08/09/2026 | By News Bureau | 112
Acepodia Receives FDA Clearance for ACE723 ADC in Advanced Liver Cancer
Acepodia’s ACE723 is designed to deliver two cytotoxic payloads to GPC3-expressing tumour cells in patients with unresectable or metastatic hepatocellular carcinoma.
US FDA | 07/09/2026 | By News Bureau
Gland Pharma's Visakhapatnam Facilities Clear US FDA GMP Inspection with Zero Observations
Gland Pharma’s Visakhapatnam facilities received a clean inspection outcome, reinforcing its compliance standards for sterile oncology formulations and API manufacturing.
US FDA | 03/09/2026 | By Akanki | 153
FDA Approves Pfizer-BioNTech's XFG-Targeted COVID-19 Vaccine for 2026-27 Season
Pfizer and BioNTech’s updated Comirnaty XFG vaccine is set to begin shipping across the US following FDA approval for the 2026–27 COVID-19 season.
US FDA | 31/08/2026 | By News Bureau
Tevimbra, Ziihera and chemotherapy combination improves overall and progression-free survival in first-line treatment of unresectable or metastatic HER2-positive gastroesophageal adenocarcinoma.
US FDA | 27/08/2026 | By News Bureau
FDA Approves Regeneron's Pasatru to Reduce New Bone Formation in FOP
Regeneron’s Pasatru has received FDA approval for adults with FOP, with Phase 3 OPTIMA data showing up to a 94 percent reduction in new heterotopic ossification lesions compared with placebo.
US FDA | 24/08/2026 | By News Bureau | 596
US FDA Seeks Public Input on Regulatory Framework for GenAI-Enabled Medical Devices
The US FDA is seeking feedback from industry, clinicians, researchers and the public on how GenAI-enabled medical devices should be evaluated and monitored.
US FDA | 21/08/2026 | By News Bureau
Acurx Pharmaceuticals Secures FDA Conditional Acceptance of Cifbezy Name for Ibezapolstat
Acurx Pharmaceuticals has secured FDA conditional acceptance of Cifbezy as the proposed brand name for ibezapolstat and received USPTO trademark allowance, marking key preparatory milestones ahead of planned international Phase 3 development for C. difficile infection.
US FDA | 18/08/2026 | By News Bureau
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