Trump jokes about potentially firing NIAID Director Anthony S. Fauci.
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The treatment is a combination of ublituximab, its investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon.
Medical company secures Investigational New Drug Application from FDA for its gummy medication.
Venclexta was previously granted provisional approval by FDA in late 2018.
The pharma maker plans to apply for FDA Emergency Use Authorization for the vaccine after the third week of November.
The pharma maker aims to make the treatment available to the most vulnerable populations by December.
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).
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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.
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.
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