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Novadoz Increases Receives FDA Approval of Thiotepa Vials for Injection
americanpharmaceuticalreview
March 09, 2020
Novadoz Pharmaceuticals received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.
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Novadoz Increases Receives FDA Approval of Thiotepa Vials for Injection
americanpharmaceuticalreview
March 09, 2020
Novadoz Pharmaceuticals received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.
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FDA approves DURYSTA™ (bimatoprost implant) New Drug Application
europeanpharmaceuticalreview
March 09, 2020
The DURYSTA ocular implant has been approved by the FDA to reduce intraocular pressure in open-angle glaucoma or ocular hypertension.
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API Supply: COVID-19 Industry Update
contractpharma
March 09, 2020
A breakdown of manufacturing facilities making active pharmaceutical ingredients (APIs) for U.S. market.
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FDA Strengthens Black Box Warning for Singulair, All Montelukast Generics
americanpharmaceuticalreview
March 06, 2020
The U.S. Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics) ...
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FDA approves Sarclisa for relapsed refractory multiple myeloma
pharmatimes
March 06, 2020
The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) for certain adults with relapsed refractory multiple myeloma (RRMM).
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FDA approves GSK’s Advil Dual Action with Acetaminophen OTC pain reliever
pharmaceutical-business-review
March 06, 2020
GlaxoSmithKline (GSK) has secured approval for Advil Dual Action with Acetaminophen from the US Food and Drug Administration (FDA) as an over-the-counter (OTC) product for pain relief.
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MedPharm Completes FDA Inspection
contractpharma
March 06, 2020
MedPharm, a global contract development organization for topical and transdermal products, has successfully completed a pre-approval inspection by the FDA at its facility in Durham, NC.
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Ayala Pharmaceuticals granted US FDA fast track designation for AL101 to treat recurrent or metastatic adenoid cystic carcinoma
pharmaceutical-business-review
March 05, 2020
Ayala Pharmaceuticals, a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers ...
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FDA Clears Novalung for Treatment of Acute Respiratory and Cardiopulmonary Failure
americanpharmaceuticalreview
March 05, 2020
Fresenius Medical Care North America (FMCNA) announced the U.S. Food and Drug Administration (FDA) has cleared Novalung®, a heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure.