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Results For "FDA"

2063 News Found

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets
News | February 25, 2021

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets

ranules now has a total of 38 ANDA approvals from US FDA.


USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis
News | February 24, 2021

USFDA denies Sun Pharma Advanced Research’s appeal of NDA for Taclantis

The company will review FDA's response and decide on appropriate next steps soon.


Zydus Cadila receives final approval from USFDA for Droxidopa capsules
News | February 20, 2021

Zydus Cadila receives final approval from USFDA for Droxidopa capsules

It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling.


Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial
Clinical Trials | December 13, 2025

Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial

Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%


Neurizon’s ALS drug regimen cleared for launch in Healey platform trial
Clinical Trials | December 12, 2025

Neurizon’s ALS drug regimen cleared for launch in Healey platform trial

The Healey ALS Platform Trial is a multicenter, double-blind, placebo-controlled


Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma
News | December 12, 2025

Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma

LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure


Zydus and Formycon secure US and Canada partnership for Keytruda biosimilar
News | December 10, 2025

Zydus and Formycon secure US and Canada partnership for Keytruda biosimilar

Formycon AG will develop, register, manufacture and supply the product, while Zydus Lifesciences Global FZE, United Arab Emirates will be responsible for the commercialization of FYB206 in the defined territories


Venus Remedies secures final Rs. 11 crore payment from Cipla for AMR drug
News | December 09, 2025

Venus Remedies secures final Rs. 11 crore payment from Cipla for AMR drug

The patented product, developed by Venus Medicine Research Centre (VMRC) for the treatment of multidrug-resistant (MDR) infections, was sold to Cipla in 2019


Capricor's cell therapy shows breakthrough results in Duchenne muscular dystrophy trial
Clinical Trials | December 09, 2025

Capricor's cell therapy shows breakthrough results in Duchenne muscular dystrophy trial

It's a development that marks a potential breakthrough for people living with the rare and debilitating disease Duchenne muscular dystrophy (DMD)