Zydus Cadila gets US FDA nod for potassium chloride extended-release tablets
It is a mineral supplement used to treat or prevent low amounts of potassium in the blood
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Drug approvals
EMA approves label update for Takeda’s HYQVIA, expands use to treat secondary immunodeficiencies
It was based on evidence from clinical trials that demonstrated that subcutaneous administration of immunoglobulin has been shown…
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…
Indoco gets USFDA nod for apixaban tablets
Apixaban is an anticoagulant, or blood thinner used for patients with health problems caused by a blood clot
Zydus Cadila gets US FDA approval for Doxorubicin Hydrochloride Liposome Injection
Liposomal doxorubicin is a chemotherapeutic agent that is used alone or with other treatments/medications to treat certain types…
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
Granules gets USFDA nod for ADHD drug dexmethylphenidate HCl extended-release capsules
The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia
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
Zydus Cadila gets tentative USFDA nod for empagliflozin and linagliptin tablets
They are oral diabetes medicines that help control blood sugar levels
Janssen gets EC approval for expanded use of IMBRUVICA (ibrutinib) plus rituximab to treat CLL
Data from Phase 3 E1912 study showed previously untreated patients aged 70 years or younger treated with ibrutinib plus rituximab…