News about "US FDA "

FDA Updates Winrevair Label With Phase 3 HYPERION Data

Merck’s Winrevair label has been updated by the US FDA to include data from the Phase 3 HYPERION trial in recently diagnosed adults with pulmonary arterial hypertension.

US FDA | 23/09/2026 | By News Bureau

FDA Grants Priority Review to Insmed's Arikayce sNDA

Insmed’s Arikayce sNDA receives FDA Priority Review for the treatment of MAC lung disease, with a PDUFA target action date of January 28, 2027.

US FDA | 22/09/2026 | By News Bureau

Concord Biotech Gujarat Plant Gets One US FDA Observation

Concord Biotech’s formulation facility in Gujarat has completed a US FDA inspection with one minor procedural observation, according to the company.

US FDA | 19/09/2026 | By News Bureau

US FDA Grants Fast Track Designation to OncoC4's Cesalatamig

US FDA grants Fast Track Designation to OncoC4’s cesalatamig for patients with NSCLC whose disease has progressed following PD-(L)1-targeted immunotherapy and platinum-based chemotherapy.

US FDA | 17/09/2026 | By News Bureau

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 |  125

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 |  164

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 |  106