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1-15 of 1898 results
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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FDA committee votes in favor of Pfizer's Xeljanz for ulcerative colitis
By PBR Staff Writer
Pfizer has received a positive response from the Gastrointestinal Drugs Advisory Committee (GIDAC) of the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) on Xeljanz (tofacitinib) to treat adult patients with moderately to severely active ulcerative colitis (UC).
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FDA grants priority review to Shionogi's lusutrombopag
Shionogi's new drug application (NDA) for lusutrombopag (S-888711) has been accepted for filing and granted priority review by the US Food & Drug Administration (FDA).
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EMA to review GW Pharmaceuticals' MAA for antiepileptic drug Epidiolex
The European Medicines Agency (EMA) has accepted for review GW Pharmaceuticals' marketing authorization application (MAA) for Epidiolex (cannabidiol) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
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EMA to review Teva's MAA for migraine prevention drug fremanezumab
By PBR Staff Writer
Teva Pharmaceutical Industries' marketing authorization application (MAA) for fremanezumab has been accepted by the European Medicines Agency (EMA) for the prevention of episodic and chronic migraine in adults.
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FDA grants fast track status to Takeda’s Zika virus vaccine candidate
By PBR Staff Writer
Takeda Pharmaceutical has secured fast track designation from the US Food and Drug Administration (FDA) for its Zika virus vaccine candidate, TAK-426.
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Synthon’s SYD985 granted FDA fast track status for pre-treated HER2-positive metastatic breast cancer
Synthon Biopharmaceuticals has secured has granted Fast track designation from the US Food & Drug Administration (FDA) for its investigational anti-HER2 antibody-drug conjugate (ADC) [vic-]trastuzumab duocarmazine (SYD985).
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CHMP recommends approval of darvadstrocel to treat complex perianal fistulas in Crohn’s disease
Takeda Pharmaceutical and TiGenix reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel).
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Pharming submits supplemental BLA to FDA for Ruconest for prophylaxis of hereditary angioedema attacks
Pharming Group has submitted a supplemental biologics license application (BLA) to the US Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE).
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Janssen seeks EMA approval for Darzalex for newly diagnosed multiple myeloma
Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency (EMA), for its immunotherapy Darzalex (daratumumab).
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1-15 of 1898 results