The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
The Trial, the first of its kind in Israel, recently obtained approval from the Israeli Ministry of Health and is preparing for participant recruitment.
Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)
Company appoints five new independent directors to reconstituted board
The card-to-cloud device was launched into the U.S. and many other markets and is designed to work without an embedded communications module.
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
WCK 5222 is a Super-drug which is entirely a new class of antibiotic known as "?-lactam ENHANCER".
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
ELCYS is the only FDA-approved cysteine hydrochloride injection on the market for use as an additive to amino acid solutions
Results consistent with previous trials, reinforcing benefit of Daiichi Sankyo and AstraZeneca’s ENHERTU in previously treated patients
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