News about "US Food and Drug Administration (FDA) "

NATCO Pharma's Kothur Facility Receives FDA EIR with VAI Classification

The US Food and Drug Administration (FDA) has completed an inspection at NATCO Pharma’s Pharma division located in Kothur, Hyderabad, India.

US Food And Drug Administration (FDA | 18/09/2025 | By Dineshwori

Biocon Biologics Secures US FDA Approval for Denosumab Biosimilars Bosaya and Aukelso

The US Food and Drug Administration (FDA) has approved Biocon Biologics' denosumab biosimilars, Bosaya (denosumab-kyqq) 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection in a single-dose vial, biosimilars of Prolia and Xgeva, respectively.

US Food And Drug Administration (FDA) | 17/09/2025 | By Dineshwori

FDA Warns Pharma Companies to Remove Misleading Ads, Issues 100 Cease-and-Desist Notices

The US Food and Drug Administration (FDA) has launched a sweeping crackdown on misleading pharmaceutical advertising, sending thousands of warning letters and issuing about 100 cease-and-desist notices to drugmakers.

US Food And Drug Administration (FDA) | 13/09/2025 | By Dineshwori

Sun Pharma Halol Facility Classified OAI by US FDA, Shipments Restricted

The US Food and Drug Administration (FDA) has classified Sun Pharma's Halol facility as “Official Action Indicated” (OAI) following an inspection conducted between June 2 and June 13, 2025.

US Food And Drug Administration (FDA) | 10/09/2025 | By Dineshwori |  100

FDA Launches 'Green List' to Crack Down on Illegal GLP-1 API Imports

The US Food and Drug Administration (FDA) has created a new “green list” import alert to stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the US market.

US Food And Drug Administration (FDA) | 09/09/2025 | By Dineshwori |  146

FDA Approves Eisai and Biogen's At-Home Alzheimer's Injection Leqembi IQLIK

Leqembi IQLIK, delivering a 360 mg dose within 15 seconds, will be available from 6 October, 2025, at a list price of USD 19,500 annually for a pack of pre-filled autoinjectors.

US Food And Drug Administration (FDA | 30/08/2025 | By Dineshwori |  161

US FDA Completes Inspection at Aurobindo Pharma's Telangana Unit

The inspection of Aurobindo Pharma’s Apitoria Unit-I facility, conducted from 21-29 August, 2025, concluded with five observations.

US Food And Drug Administration (FDA | 30/08/2025 | By Dineshwori |  181

US FDA Clears Sanofi's Wayrilz, First BTK Inhibitor for ITP

The US FDA approval was based on the pivotal LUNA 3 phase-III study, in which Sanofi’s Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms.

US Food And Drug Administration (FDA) | 30/08/2025 | By Dineshwori

Teva Pharmaceuticals Launches First Generic Version of Saxenda in US

The first generic version of Saxenda, Liraglutide injection, is approved for adults with obesity or overweight who have weight-related medical conditions, as well as for paediatric patients aged 12 to 17 years weighing more than 60 kg with obesity.

US Food And Drug Administration (FDA) | 30/08/2025 | By Dineshwori |  270

US FDA Accepts Gadoquatrane for Review: Bayer

Bayer has submitted New Drug Application (NDA) for low dose contrast agent gadoquatrane to seek approval for contrast-enhanced Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS) and other body regions for adults and paediatric patients including neonates.

US Food And Drug Administration (FDA) | 27/08/2025 | By Dineshwori