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151-165 of 1882 results
Emmaus Life Sciences submits NDA to FDA for sickle cell disease treatment
Emmaus Life Sciences has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) requesting marketing approval for its orally administered pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell disease.
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Merck’s Keytruda wins FDA breakthrough therapy status, priority review for first-line NSCLC
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation and priority review to Merck’s Keytruda (pembrolizumab) for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1.
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Aerie submits NDA to FDA for Rhopressa (netarsudil ophthalmic solution) 0.02%
Aerie Pharmaceuticals has submitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Rhopressa (netarsudil ophthalmic solution) 0.02%.
Production & Manufacturing > Process & Production > News
FDA accepts CCP-07 new drug application for full review
Vernalis and Tris Pharma announced that the US Food and Drug Administration (FDA) has accepted the CCP-07 New Drug Application (NDA) for full review.
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FDA grants orphan drug status to Catalyst Pharmaceuticals' Firdapse for myasthenia gravis
The US Food and Drug Administration (FDA) has granted Catalyst Pharmaceuticals orphan drug designation for Firdapse (amifampridine phosphate) for the treatment of myasthenia gravis.
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Dynavax says PDUFA date for HEPLISAV-B remains unchanged
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research has cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review Dynavax Technologies' Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)].
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Biogen’s Alzheimer’s drug gets FDA fast-track status
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation to Biogen’s investigational Alzheimer’s disease (AD) treatment aducanumab.
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ARIAD completes rolling submission of NDA for Brigatinib to FDA
ARIAD Pharmaceuticals has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA).
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Tonix announces successful end-of-phase 2 meeting with FDA for TNX-102 SL in PTSD
Tonix Pharmaceuticals, which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), has received the final meeting minutes from the U.S. Food and Drug Administration (FDA) from an End-of-Phase 2/Pre-Phase 3 meeting.
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Alexion Pharmaceuticals’ ALXN1007 secures EU orphan drug status
Alexion Pharmaceuticals has secured orphan drug designation from the European Commission for ALXN1007 to treat patients with Graft-Versus-Host Disease (GVHD).
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Mallinckrodt’s DMD drug receives FDA fast track designation
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Mallinckrodt’s request for a fast track designation of its new Duchenne muscular dystrophy (DMD) drug, Synacthen Depot.
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European Medical Agency to review Mylan and Biocon’s anti cancer biosimilar
By PBR Staff Writer
The European Medicines Agency (EMA) has accepted for review Mylan's marketing authorization application (MAA) for a proposed biosimilar Trastuzumab to treat several HER2-positive breast and gastric cancers.
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FDA issues complete response letter for Amgen's NDA for Parsabiv
The US Food and Drug Administration (FDA) has issued a Complete Response Letter for Amgen's New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
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Evgen Pharma gets FDA orphan drug designation for stabilised sulforaphane
The US Food & Drug Administration (FDA) has granted Evgen Pharma orphan drug designation for the use of stabilised sulforaphane for the treatment of subarachnoid haemorrhage (SAH).
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FDA grants priority review to Clovis’ rucaparib for advanced BRCA-mutated ovarian cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review status to Clovis Oncology’s new drug application (NDA) for rucaparib as a treatment for patients with BRCA-positive advanced ovarian cancer who have received at least two or more prior lines of chemotherapy.
Production & Manufacturing > Process & Production > News
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