INOVIO COVID-19 vaccine trials on partial hold after additional queries from US FDA
Working to address the FDA's questions and plans to respond in October, informed the company
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US FDA
Lupin launches atorvastatin calcium tablets
It is indicated to lower cholesterol in blood for adults and children over 10 years of age
Dr Reddy’s launches dimethyl fumarate DR capsules in US
It is a therapeutic equivalent generic version of Tecfidera
Granules gets US FDA nod for OTC naproxen sodium and diphenhydramine hydrochloride tablets
They are indicated for relief of occasional sleeplessness associated with minor aches and pains
US FDA approves Zydus Cadila’s dimethyl fumarate DR capsules
These tablets will be manufactured at the group’s manufacturing facility at the SEZ, Matoda
Lupin launches divalproex sodium ER tablets
The product will be manufactured at Lupin’s Nagpur facility in India
Trodelvy from Immunomedics extends survival in breast cancer patients
The FDA granted the drug accelerated approval for its use in metastatic triple-negative breast cancer (mTNBC) patients who had…
Sorrento gets US FDA nod for Phase 1 clinical trial of neutralising antibody in COVID-19 patients
Sorrento had earlier informed that COVI-GUARD (STI-1499) demonstrated 100 per cent in vitro neutralizing effect against SARS-CoV-2…
US FDA denies approval to Mallinckrodt for Terlipressin to treat Hepatorenal Syndrome Type 1
The Complete Response Letter stated that, based on the available data, the agency cannot approve the terlipressin NDA in its…
Kiadis to collaborate with Abigail Wexner Research Institute for clinical trials of COVID-19 therapy
The US FDA approved AWRI’s investigational new drug application (IND) for a study in an adult population with off-the-shelf…