Gilead gets approval for Jyseleca (filgotinib) in Japan for rheumatoid arthritis
Gilead Japan will hold marketing authorisation of Jyseleca in Japan while Eisai will be responsible for product distribution
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Drug approvals
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
Cipla gets US FDA approval for dimethyl fumarate DR capsules
It is indicated for the treatment of relapsing forms of multiple sclerosis
Zydus Cadila receives tentative USFDA approval for palbociclib capsules
It is an anti-cancer medicine that interferes with the growth and spread of cancer cells in the body
Strides gets USFDA approval for butalbital, acetaminophen and caffeine tablets
They are indicated for the relief of the symptom complex of tension or muscle contraction headache
Bayer gets DCGI nod for intravitreal aflibercept injection, Eylea to treat diabetic macular edema
Intravitreal Aflibercept is administered via injection directly in the area of swelling in the eye
Roche gets positive CHMP opinion for Tecentriq plus Avastin to treat liver cancer
The recommendation from the CHMP is based on results from the Phase III IMbrave150 study, which showed that Tecentriq in…
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
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…
Alembic Pharma gets tentative USFDA approval for Treprostinil injection
It is indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise
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