Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
The approval is based on a comprehensive package of analytical, nonclinical, and clinical data
The inspection concluded with zero Form 483 observations
Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals USA
J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA
Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
The company will provide the necessary response to USFDA within stipulated 15 days
The company received seven observations in the Form-483
Sun Pharma gets 8 observations from USFDA for Halol facility
The company received one observation in the Form-483
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Now approved for both acute and chronic HCV in adults and children aged 3 and above
The company received 1 (One) observation in the Form-483
Zydus receives EIR for the API manufacturing facility at Ankleshwar
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
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