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512 News Found

Zydus receives final approval from the USFDA for Erythromycin Tablets
Drug Approval | March 10, 2023

Zydus receives final approval from the USFDA for Erythromycin Tablets

Erythromycin Tablets USP, 250 mg and 500 mg are used to prevent and treat infections in many different parts of the body


Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution
Drug Approval | March 06, 2023

Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution

Vigabatrin for Oral Solution USP, 500 mg had annual sales of US $233.7 mn in US


Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution
Drug Approval | March 04, 2023

Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution

Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States


Zydus receives final approval from the USFDA for Apixaban Tablets
Drug Approval | March 01, 2023

Zydus receives final approval from the USFDA for Apixaban Tablets

Apixaban Tablets, 2.5 mg and 5 mg had annual sales of USD 18,876 mn in the United States (IQVIA MAT Dec. 2022).


Zydus receives final approval from the USFDA for Hydrochlorothiazide Tablets
Drug Approval | March 01, 2023

Zydus receives final approval from the USFDA for Hydrochlorothiazide Tablets

This combination medicine is used to treat high blood pressure (hypertension).


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Bluestem Biosciences files 24 patent applications
News | February 21, 2023

Bluestem Biosciences files 24 patent applications

At commercial scale, Bluestem's patent pending technologies will reduce carbon emission by an estimated 75% or more and be cost-competitive with petroleum based chemicals


Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
Drug Approval | February 20, 2023

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States


USFDA accepts for priority review the sNDA for Merck’s Prevymis
Drug Approval | February 18, 2023

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients