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Results For "Food-and-Drug-Administration"

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FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer
Drug Approval | August 17, 2022

FDA accepts submission of olaparib in combination with abiraterone and prednisone for prostate cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations


Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP
Drug Approval | August 16, 2022

Lupin receives approval from U.S. FDA for Meclizine Hydrochloride Tablets USP

Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.


Unichem receives ANDA approval for quetiapine extended-release tablets
Drug Approval | August 16, 2022

Unichem receives ANDA approval for quetiapine extended-release tablets

Quetiapine Extended-Release Tablets are indicated for the treatment of Schizophrenia, Bipolar disorder and adjunctive treatment of Major Depressive Disorder (MDD)


Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP
Drug Approval | August 13, 2022

Lupin receives USFDA approval for Meclizine Hydrochloride Tablets USP

The product will be manufactured at Lupin’s facility in Goa, India.


Roche gets USFDA approval of Xofluza to treat influenza in children
Drug Approval | August 13, 2022

Roche gets USFDA approval of Xofluza to treat influenza in children

Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age


Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer
News | August 13, 2022

Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer

Based on DESTINY-Lung02 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu reported a confirmed objective response rate of 57.7% in patients with HER2-mutant disease


ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer
Drug Approval | August 09, 2022

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy


Biocon Sdn. Bhd. enters Malaysia Book of Records
Biotech | August 08, 2022

Biocon Sdn. Bhd. enters Malaysia Book of Records

The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR


Zydus receives final approval from the USFDA for Ivermectin Cream
Drug Approval | August 04, 2022

Zydus receives final approval from the USFDA for Ivermectin Cream

Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.


Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee
News | August 03, 2022

Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee

he US FDA has issued six observations pursuant to the completion of the audit.