The pharma maker aims to make the treatment available to the most vulnerable populations by December.
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Simponi Aria is now approved to to treat patients 2 years and older with active polyarticular juvenile Idiopathic arthritis (pJIA) and psoriatic arthritis (PsA).
The combination therapy of Opdivo plus Yervoy will treat the cancer caused by inhaling asbestos fibers.
The recall is attributed to higher levels of the carcinogenic ingredient NDMA than are allowed.
Pfizer snagged its fourth indication for the blockbuster medication tofacitinib (Xeljanz) for children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA).
Xanax and Ativan are among the medications impacted by FDA’s new requirements.
Sun Pharmaceuticals issued a voluntary recall of 1 lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL.
Some of the top medications were approved this summer, while others are awaiting FDA approval.
Both recalls are due to sub-potency of drugs that treat hypothyroidism.
The top-selling diabetes drug will join semaglutide (Ozempic), which is approved to reduce the risk of major adverse cardiovascular events.
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The treatment is the first anti-PD-1 antibody from China to receive Breakthrough therapy designation.
Pharma makers expect the treatment to be available within a week.
The medication boasts a statistically significant improvement in overall survival versus placebo.
FDA expands emergency use authorization for remdesivir to include all hospitalized COVID-19 patients
One study questions the effectiveness of remdesivir past day 10 while others support its expanded use.
The pharma maker will initially produce 150 million of the 5-minute tests.
Drug for a specific Duchenne muscular dystrophy mutation is only the second drug approved for the mutation.
The drug’s indication for marginal zone lymphoma (MZL) may not be approved until February 2021.
Evrysdi is only the second drug approved to treat the rare disease.
Olinvyk is the first new chemical entity in this IV drug class in decades.
The chimeric antigen receptor (CAR) T cell therapy is the first of its kind for mantle cell lymphoma (MCL).
Esketamine (Spravato) can now be used to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.
The drug is the first treatment approved for active psoriatic arthritis that selectively inhibits interleukin (IL)-23.
The PBM overcharged for generic drugs, among other offenses, a new lawsuit claims.
The pharma maker is partnering with the nonprofit Civica Rx to help reduce shortages in hospitals.
Five other manufacturers have recalled the popular diabetes medication due to the presence of a the carcinogenic ingredient.
Gilead will present new data on virologic suppression in adults 65 years and older at AIDS 2020: Virtual this week.
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