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8882 News Found

Qdenga approved in Indonesia for use regardless of prior dengue exposure
Drug Approval | August 28, 2022

Qdenga approved in Indonesia for use regardless of prior dengue exposure

Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age


Novartis to spin-off Sandoz business to a standalone company
News | August 28, 2022

Novartis to spin-off Sandoz business to a standalone company

Sandoz is planned to be incorporated in Switzerland and to be listed on the SIX Swiss Exchange, with an American Depositary Receipt (ADR) program in the US


Glenmark receives OAI from USFDA for Goa facility
News | August 28, 2022

Glenmark receives OAI from USFDA for Goa facility

Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.


Moderna files for emergency use of BA.4/BA.5 Omicron booster
Biotech | August 28, 2022

Moderna files for emergency use of BA.4/BA.5 Omicron booster

Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September


Cipla receives 6 observations from USFDA for Goa facility
Drug Approval | August 28, 2022

Cipla receives 6 observations from USFDA for Goa facility

There are no data integrity (DI) observations.


Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada
News | August 27, 2022

Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada

With the receipt of the EIR, the inspection stands successfully closed.


Lupin launches Desvenlafaxine extended-release tablets in the US
News | August 27, 2022

Lupin launches Desvenlafaxine extended-release tablets in the US

Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.


Pristyn Care witnesses industry highest adoption of EMR
Healthcare | August 26, 2022

Pristyn Care witnesses industry highest adoption of EMR

99% of Pristyn Doctors are using EMR facility on its doctor app


US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad
News | August 26, 2022

US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad

The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.


Lupin receives approval from US FDA for Formoterol Fumarate Inhalation Solution
Drug Approval | August 25, 2022

Lupin receives approval from US FDA for Formoterol Fumarate Inhalation Solution

Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US