Drug Approval | October 02, 2024
Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022
The observations are of procedural in nature and will be responded to within the stipulated time
The inspection concluded with the issuance of a form 483 with five observations
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression
A first-in-class muscarinic agonist for the treatment of schizophrenia in adults
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
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