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Genentech seeks FDA approval for Venclexta for AML
Roche’s Genentech has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Venclexta (venetoclax), in combination with either a hypomethylating agent or low dose cytarabine (LDAC), for the treatment of acute myeloid leukemia (AML) in previously untreated patients who are ineligible for intensive chemotherapy.
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EMA accepts Clovis’ application for expanded indication of Rubraca to treat ovarian cancer
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.
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CHMP recommends approval of Ablynx’s Cablivi to treat aTTP
Sanofi said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its subsidiary Ablynx’s Cablivi (caplacizumab) for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.
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CHMP recommends approval of Puma’s breast cancer drug Neratinib
By PBR Staff Writer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has reversed its stance on Puma Biotechnology’s breast cancer drug Neratinib by adopting a positive trend vote for its approval in the Europe.
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Alexion seeks approval from FDA for PNH drug ALXN1210
Alexion Pharmaceuticals said that it has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA), seeking approval for its C5 complement inhibitor ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH).
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Celltrion resubmits aBLA to FDA for proposed Trastuzumab biosimilar
South Korea-based Celltrion said that it has completed a re-submission to the US Food and Drug Administration (FDA) seeking approval for CT-P6, a proposed mAb biosimilar to cancer drug Herceptin (trastuzumab).
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UK's MHRA, CHM adopt positive opinion on approval of Alliance Pharma's Diclectin
Alliance Pharma said that the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) have adopted a positive opinion for the approval of Diclectin.
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Roche’s Hemlibra gets FDA priority review for new haemophilia A indication
By PBR Staff Writer
Roche’s Hemlibra (emicizumab) has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of haemophilia A without factor VIII inhibitors in both adults and children.
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Malvern Panalytical unveils Zetasizer Pro and Ultra systems
Malvern Panalytical has launched its new Zetasizer Pro and Ultra systems, designed to help in decision-making within crucial analytical workflows associated to product development and quality control.
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FDA committee recommends approval of Akcea’s FCS drug
The US Food and Drug Administration’s (FDA) division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Akcea Therapeutics' Waylivratm (volanesorsen) for the treatment of familial chylomicronemia syndrome (FCS).
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Roche’s Tecentriq combo gets FDA priority review to treat lung cancer
By PBR Staff Writer
Roche’s cancer immunotherapy Tecentriq (atezolizumab) in combination with chemotherapy has been granted priority review in the US for the treatment of a specific type of metastatic lung cancer.
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AbbVie seeks US approval for psoriasis drug risankizumab
By PBR Staff Writer
AbbVie has submitted a biologics license application (BLA) to the US Food and Drug Administration seeking approval of risankizumab for the treatment of moderate to severe plaque psoriasis.
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Verastem’s lymphoma drug duvelisib gets FDA priority review designation
The US Food and Drug Administration (FDA) has accepted Verastem's new drug application for its lead product candidate duvelisib and grated priority review.
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Dr. Reddy’s, Promius Pharma file NDA with FDA for migraine candidate
By PBR Staff Writer
Dr. Reddy’s Laboratories and its subsidiary Promius Pharma have filed a new drug application (NDA) with the US Food and Drug Administration (USFDA) for migraine candidate DFN-02.
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Sarepta plans to submit NDA for Golodirsen Duchenne drug by year end
Sarepta Therapeutics has is planning to submit a new drug application (NDA) for accelerated approval of its duchenne muscular dystrophy (DMD) drug Golodirsen (SRP-4053).
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