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Intarcia seeks US approval for ITCA 650 to treat type 2 diabetes
Intarcia Therapeutics has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ITCA 650 to treat type 2 diabetes (T2D).
Production & Manufacturing > Process & Production > News
Janssen seeks US approval for guselkumab to treat plaque psoriasis
By PBR Staff Writer
Janssen Biotech is seeking approval in the US for guselkumab to treat adults living with moderate to severe plaque psoriasis.
Production & Manufacturing > Process & Production > News
Amplyx's APX001 gets FDA orphan drug status to treat multiple invasive fungal infections
The US Food and Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation to Amplyx Pharmaceuticals' lead drug candidate APX001 to treat multiple invasive fungal and mold infections.
Production & Manufacturing > Process & Production > News
FDA grants priority review to Novartis' PKC412 for AML and mastocytosis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted under priority review Novartis' new drug application (NDA) seeking approval of breakthrough therapy-designated PKC412 (midostaurin) investigational, oral, multi-targeted kinase inhibitor to treat acute myeloid leukemia (AML).
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European CHMP issues positive opinion recommending Suliqua for approval
Sanofi has received a positive opinion from the Committee for Medicinal Product for Human Use (CHMP) of the European Medicines Agency (EMA) recommending approval of Suliqua(TM), the once-daily titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes.
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FDA accepts to review Emmaus Life Sciences' NDA for sickle cell disease
The US Food and Drug Administration (FDA) has accepted for review Emmaus Life Sciences' New Drug Application for its orally administered pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell disease.
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Bayer seeks FDA approval for Stivarga to treat advanced liver cancer
By PBR Staff Writer
Bayer is seeking the US Food and Drug Administration (FDA) approval for Stivarga (regorafenib) for advanced liver cancer.
Production & Manufacturing > Process & Production > News
Amryt secures FDA orphan drug designation for acromegaly compound
Clinical-stage specialty pharmaceutical firm Amryt has secured orphan drug designation from the US Food and Drug Administration (FDA) for its drug compound, AP102, which has the potential to treat patients with acromegaly.
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FDA grants orphan drug status for AbbVie's veliparib to treat advanced squamous NSCLC
AbbVie has received has Orphan Drug Designation from the US Food and Drug Administration (FDA) for veliparib, an oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, being investigated in combination with chemotherapies, such as carboplatin and paclitaxel, or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).
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European regulator accepts to review Mylan’s MAA for insulin glargine
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted for review Mylan's marketing authorization application (MAA) for insulin glargine.
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EMA validates avelumab MAA for rare skin cancer
By PBR Staff Writer
The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for avelumab for the proposed indication of metastatic Merkel cell carcinoma (MCC).
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EMA accepts to evaluate PharmaMar's MAA for Aplidin
The European Medicines Agency (EMA) has accepted to assess PharmaMar's Marketing Authorization Application (MAA) for Aplidin (plitidepsin) in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM).
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Adamas submits new drug application to FDA for ADS-5102
Adamas Pharmaceuticals has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, the company's lead product candidate, for the potential treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).
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Portola seeks US approval for Betrixaban for extended duration prophylaxis of VTE in acute medically ill patients
Portola Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
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GlaxoSmithKline seeks US approval for shingles vaccine Shingrix
By PBR Staff Writer
GlaxoSmithKline (GSK) is seeking regulatory approval in the US for its experimental shingles vaccine, Shingrix.
Production & Manufacturing > Process & Production > News
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