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31-45 of 1882 results
Kite Pharma seeks European approval for Axicabtagene Ciloleucel
Kite Pharma has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are not eligible for autologous stem cell transplant.
Production & Manufacturing > Process & Production > News
Eagle gets complete response letter from FDA on exertional heat stroke drug RYANODEX
Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
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CHMP issues positive opinion for Daiichi Sankyo's LIXIANA label update
The European Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a label update for Daiichi Sankyo Europe's LIXIANA, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion.
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FDA advisory panel recommends Pfizer’s Mylotarg for acute myeloid leukemia
By PBR Staff Writer
Pfizer’s Mylotarg (gemtuzumab ozogamicin) has been recommended for approval by the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) to treat acute myeloid leukemia (AML).
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Amicus plans to submit NDA to FDA for migalastat for fabry disease
Amicus Therapeutics has revealed its plans to file a new drug application (NDA) with the US FDA for the oral precision medicine migalastat for Fabry disease in the fourth quarter of the year.
Production & Manufacturing > Process & Production > News
BioMarin submits Pegvaliase BLA to FDA for treatment of phenylketonuria
BioMarin Pharmaceutical has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management.
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FDA accepts for filing Icon’s NDA for Dexycu drug therapy
The US Food and Drug Administration (FDA) has accepted for filing Icon Bioscience (IBI), recently submitted new drug application (NDA) for Dexycu (IBI-10090), a novel drug for treating inflammation associated with cataract surgery.
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Pfizer gets CRL on Epogen biosimilar from FDA
By PBR Staff Writer
The United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Pfizer in connection with its biosimilar candidate to Amgen’s anemia drug Epogen (epoetin alfa).
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Axovant’s dementia drug granted FDA fast track designation
Axovant Sciences’ investigational drug nelotanserin has secured fast track designation from the US Food and Drug Administration (FDA) for the treatment of visual hallucinations disorder in dementia with Lewy bodies (DLB).
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Omeros’ OMS721 kidney drug gets FDA breakthrough therapy status
By PBR Staff Writer
Omeros’ MASP-2 inhibitor OMS721 has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of Immunoglobulin A (IgA) nephropathy.
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FDA accepts Synergy’s sNDA for Trulance to treat adults with IBS-C
The US Food and Drug Administration (FDA) has accepted Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
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Sunovion receives complete response letter from FDA for SUN-101/eFlow for COPD
Sunovion Pharmaceuticals has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate) for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), such as chronic bronchitis and/or emphysema.
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UK’s NICE recommends Novartis’ Afinitor to treat neuroendocrine tumours
By PBR Staff Writer
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ Afinitor (everolimus) to treat unresectable or metastatic neuroendocrine tumours (NETs) in patients with progressive disease.
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EMA's CHMP backs Novartis' Zykadia for first-line use in lung cancer
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis' Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
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Amgen submits BLA of migraine prevention drug to FDA
Amgen has submitted the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for erenumab to prevent migraine.
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31-45 of 1882 results