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1152 News Found

Alembic Pharmaceuticals receives USFDA tentative approval for heart failure drug
Drug Approval | April 20, 2022

Alembic Pharmaceuticals receives USFDA tentative approval for heart failure drug

Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA


BDR Pharmaceuticals launch Furmecil to treat advanced gastric cancer
Drug Approval | April 20, 2022

BDR Pharmaceuticals launch Furmecil to treat advanced gastric cancer

The launch is yet another first of its kind innovation in India


Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets
Drug Approval | April 18, 2022

Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India


Zydus to supply Sagent's caffeine citrate oral solution from Jarod
Biotech | April 13, 2022

Zydus to supply Sagent's caffeine citrate oral solution from Jarod

This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants


Alembic gets USFDA tentative approval for dabigatran etexilate capsules
Drug Approval | April 07, 2022

Alembic gets USFDA tentative approval for dabigatran etexilate capsules

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim


Lupin launches Merzee capsules in the United States
Drug Approval | April 07, 2022

Lupin launches Merzee capsules in the United States

Merzee is a generic equivalent of Taytulla of Allergan Pharmaceuticals International


Alvotech and STADA pave way to launching Hukyndra
Biotech | April 06, 2022

Alvotech and STADA pave way to launching Hukyndra

All intellectual-property disputes related to the market entry of Alvotech’s AVT02 (adalimumab) in the U.S. and Europe are now resolved


Dysval gets regulatory approval in Japan
Drug Approval | March 29, 2022

Dysval gets regulatory approval in Japan

Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients


EU approves Evusheld to prevent Covid-19
Drug Approval | March 28, 2022

EU approves Evusheld to prevent Covid-19

Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months


Evusheld recommended for market authorisation in EU
Biotech | March 25, 2022

Evusheld recommended for market authorisation in EU

Recommendation based on Phase III PROVENT trial showing a significant reduction in the risk of developing symptomatic COVID-19, with protection lasting at least six months