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
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US FDA
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…
Junshi Biosciences gets US FDA Breakthrough Therapy Designation for Toripalimab to treat…
It is the first anti-PD-1 antibody from China to receive BTD
GSK gets US FDA approval for Trelegy Ellipta to treat asthma, COPD
Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD
Dr Reddy’s Laboratories launches Fulvestrant Injection in US
Fulvestrant is an estrogen receptor antagonist indicated for the treatment of HR-positive advanced breast cancer
Lilly gets US FDA nod for additional doses of Trulicity (dulaglutide) to treat type 2 diabetes
The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11 trial