News about "Food and Drug Administration "

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.

Food And Drug Administration | 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.

Food And Drug Administration | 10/09/2026 | By News Bureau

Ascletis Initiates US Phase 1 Study of Oral ASC36 for Obesity

Ascletis has initiated a US Phase 1 study of ASC36, an investigational oral amylin receptor peptide agonist developed using the company’s proprietary oral peptide delivery technology.

Food And Drug Administration | 09/09/2026 | 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.

Food And Drug Administration | 08/09/2026 | By News Bureau |  105

Maharashtra FDA Conducts 2,902 Inspections, Acts Against 880 Drug Licence Holders

Maharashtra FDA’s intensified inspections identified compliance gaps across pharmaceutical manufacturing, sales, blood centres and storage facilities.

Food And Drug Administration | 08/09/2026 | By News Bureau

Rezubio Advances RZ-520 Into Phase 1 Trial Following FDA and NMPA Clearances

Rezubio has dosed the first cohort in a Phase 1 trial evaluating RZ-520, an investigational inhaled therapy for chronic respiratory diseases.

Food And Drug Administration | 08/09/2026 | By News Bureau

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.

Food And Drug Administration | 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.

Food And Drug Administration | 03/09/2026 | By Akanki |  151

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.

Food And Drug Administration | 31/08/2026 | By News Bureau

Maharashtra FDA Cancels Cipla Pharma's C&F Drug Licences in Pune Over Regulatory Violations

Maharashtra FDA has cancelled Cipla Pharma & Life Sciences’ C&F drug sale and distribution licences at Vadki, Pune, citing violations linked to misbranded ‘Reactin Plus’ tablets, storage deficiencies, inventory discrepancies and non-compliance with recall directions.

Food And Drug Administration | 31/08/2026 | By News Bureau