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Results For "approvaL"

2475 News Found

Biological E. announces CDSCO recommendation of its infant’s vaccine
Drug Approval | September 01, 2022

Biological E. announces CDSCO recommendation of its infant’s vaccine

Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)


USFDA completes inspection at Aurolife Pharma’s Raleigh unit
Drug Approval | August 29, 2022

USFDA completes inspection at Aurolife Pharma’s Raleigh unit

The unit has filed 2 Derma products and 1 MDI product.


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


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.


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.


Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer
Drug Approval | August 26, 2022

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients


Merck gets fast track designation from the USFDA for anticoagulant therapy
Drug Approval | August 24, 2022

Merck gets fast track designation from the USFDA for anticoagulant therapy

Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis


Glenmark  receives OAI communication from US FDA
Drug Approval | August 24, 2022

Glenmark receives OAI communication from US FDA

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


Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension
Drug Approval | August 24, 2022

Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension

The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA


DCGI approves AstraZeneca 's Olaparib film-coated tablets
Drug Approval | August 20, 2022

DCGI approves AstraZeneca 's Olaparib film-coated tablets

Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer