Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 12

Results For "US-Food-and-Drug-Administration"

142 News Found

New data show Lynparza demonstrated overall survival benefit in early breast cancer
Biotech | March 12, 2022

New data show Lynparza demonstrated overall survival benefit in early breast cancer

Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial


Fitch revises outlook on Jubilant Pharma to negative; affirms at 'BB'
News | February 19, 2022

Fitch revises outlook on Jubilant Pharma to negative; affirms at 'BB'

Fitch estimates JPL's EBITDA to drop significantly in FY23 due to lower volume and narrowing of the margin to 11% (FY22 estimate: 14%).


USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test
Healthcare | February 15, 2022

USFDA grants Breakthrough Designation for Datar’s early-stage prostate cancer detection blood test

Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation


Granules Pharmaceuticals concludes USFDA audit with three minor observations
News | January 31, 2022

Granules Pharmaceuticals concludes USFDA audit with three minor observations

The audit is a PAI for two of its product applications filed from this facility


Eplontersen granted Orphan Drug Designation in the US
Biotech | January 24, 2022

Eplontersen granted Orphan Drug Designation in the US

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US


US FDA approves Idorsia’s insomnia drug
Drug Approval | January 21, 2022

US FDA approves Idorsia’s insomnia drug

Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain


Green Valley receives US FDA approval for Phase II clinical trial for Parkinson’s disease
Biotech | January 17, 2022

Green Valley receives US FDA approval for Phase II clinical trial for Parkinson’s disease

The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period


Emcure to launch oral Covid-19 drug soon
Drug Approval | January 03, 2022

Emcure to launch oral Covid-19 drug soon

A toll-free helpline to be set up to help doctors and patients


Ascletis expands ritonavir oral tablet production
Biotech | January 03, 2022

Ascletis expands ritonavir oral tablet production

ASC10 is an oral direct-acting antiviral drug candidate targeting RNA dependent RNA polymerase (RdRp) to treat SARS-CoV-2 infection


Evusheld neutralises Omicron in latest studies
News | December 23, 2021

Evusheld neutralises Omicron in latest studies

Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19