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76-90 of 1845 results
Agilis' AADC gene therapy candidate gets OMP designation in Europe
Agilis Biotherapeutics’ gene therapy product candidate, AGIL-AADC has secured Orphan Medicinal Product (OMP) designation from the European Commission (EC).
Production & Manufacturing > Process & Production > News
Daiichi Sankyo’s breast cancer drug candidate gets FDA fast track designation
Daiichi Sankyo has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational HER2-targeting antibody drug conjugate DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).
Production & Manufacturing > Process & Production > News
AbbVie’s risankizumab secures FDA orphan drug status for paediatric Crohn’s
AbbVie has secured Orphan Drug Designation from the US Food and Drug Administration (FDA) to risankizumab (ABBV-066; formerly BI 655066) for the investigational treatment of Crohn's disease in pediatric patients.
Production & Manufacturing > Process & Production > News
FDA grants priority review to EMD Serono’s BLA for avelumab for Merkel cell carcinoma
The US Food and Drug Administration (FDA) has granted priority review for EMD Serono’s biologics license application (BLA) of avelumab to treat metastatic Merkel cell carcinoma (MCC).
Production & Manufacturing > Process & Production > News
FDA grants priority review to Merck’s sBLA for Keytruda for MSI-H cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review to Merck’s supplemental biologics license application (sBLA) seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high (MSI-H) cancer.
Production & Manufacturing > Process & Production > News
Intellipharmaceutics seeks FDA approval for Rexista to treat moderate to severe pain
Intellipharmaceutics International has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ("FDA") seeking authorization to market its abuse-deterrent oxycodone hydrochloride extended release tablets branded as Rexista in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg strengths.
Production & Manufacturing > Process & Production > News
GSK seeks EU approval for shingles vaccine
GlaxoSmithKline (GSK) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for its shingles vaccine candidate dubbed Shingrix, for herpes zoster (shingles) prevention in people aged 50 years or over.
Production & Manufacturing > Process & Production > News
Green Cross gets complete response letter from FDA for IVIG-SN
Green Cross has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for IVIG-SN (human normal immunoglobulin G for intravenous administration) intended for the treatment of primary immunodeficiency diseases.
Production & Manufacturing > Process & Production > News
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).
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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
76-90 of 1845 results