Drug Approval | January 17, 2025
FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3
With over 28 years of experience in the pharmaceutical industry, he is a seasoned Techno? Commercial professional and accomplished top management leader
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
PROVIGIL and NUVIGIL are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy
The overall clinical efficacy of Zaynich across indications was 98% at the test-of-cure
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