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Results For "Food-and-Drug-Administration"

1074 News Found

Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster
Diagnostic Center | November 21, 2022

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster

Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data


USFDA completes pre-approval inspection of BHL's Vadodara facility
Drug Approval | November 21, 2022

USFDA completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited


Aurobindo Pharma receives 10 observations for Unit IX
Drug Approval | November 21, 2022

Aurobindo Pharma receives 10 observations for Unit IX

The company had responded to the agency and carried out the required corrective actions.


Biocon Biologics features on ASIA IP ELITE List 2022
News | November 14, 2022

Biocon Biologics features on ASIA IP ELITE List 2022

This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list


YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine
Drug Approval | November 11, 2022

YS Biopharma announces USFDA clearance of IND Application for PIKA COVID-19 vaccine

PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.


Lupin receives tentative approval from USFDA for Doxycycline Capsules
Drug Approval | November 09, 2022

Lupin receives tentative approval from USFDA for Doxycycline Capsules

Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US


Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Drug Approval | November 09, 2022

Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India


Zydus receives EIR with VAI from USFDA for Moraiya facility
Drug Approval | November 08, 2022

Zydus receives EIR with VAI from USFDA for Moraiya facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)