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121-135 of 1862 results
Regenicin schedules pre-IND meeting with FDA for new autologous cultured skin substitute
Biotechnology company Regenicin will have a Pre-IND Meeting via teleconference regarding its product NovaDerm with members of the FDA Office of Cellular, Tissue, and Gene Therapies (OCTGT) in the Center for Biologics Evaluation and Research (CBER) on 27 October.
Production & Manufacturing > Process & Production > News
FDA grants priority review to Genentech’s Lucentis' sBLA for Myopic Choroidal Neovascularization
The US Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness.
Production & Manufacturing > Process & Production > News
FDA grants priority review for Genmab's Daratumumab in relapsed multiple myeloma
The US Food and Drug Administration (FDA) has granted Priority Review to Genmab's supplemental Biologics License Application (sBLA) for the use of daratumumab (DARZALEX) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat patients with multiple myeloma who have received at least one prior therapy.
Production & Manufacturing > Process & Production > News
Roche’s Actemra/RoActemra gets FDA breakthrough therapy status for giant cell arteritis
By PBR Staff Writer
Roche and Chugai Pharmaceutical have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Actemra/RoActemra (tocilizumab) for giant cell arteritis (GCA).
Production & Manufacturing > Process & Production > News
FDA grants breakthrough therapy status to AbbVie's investigational HCV regimen
By PBR Staff Writer
AbbVie has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) to treat patients with hepatitis C virus infection who failed previous direct-acting antiviral (DAA) therapy.
Production & Manufacturing > Process & Production > News
FDA grants rare pediatric disease designation to Summit Therapeutics’ DMD drug
By PBR Staff Writer
Summit Therapeutics has received second drug designation from the US Food and Drug Adminstration for ezutromid, a treatment for Duchenne Muscular Dystrophy (DMD).
Production & Manufacturing > Process & Production > News
Janssen Biotech files US regulatory application for Sirukumab in rheumatoid arthritis
By PBR Staff Writer
Janssen Biotech is seeking approval for sirukumab in the US to treat adults with moderately to severely active rheumatoid arthritis (RA).
Production & Manufacturing > Process & Production > News
EMA’s CHMP recommends approval for three new cancer drugs
By PBR Staff Writer
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended three cancer drugs for approval.
Production & Manufacturing > Process & Production > News
GSK and Janssen seek European approval for sirukumab in rheumatoid arthritis
By PBR Staff Writer
GlaxoSmithKline (GSK) and Janssen-Cilag International have submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of sirukumab to treat moderately to severely active rheumatoid arthritis (RA) in adults.
Production & Manufacturing > Process & Production > News
FDA grants orphan drug status to Ovid’s OV101 for genetic neurologic disorder
By PBR Staff Writer
Ovid Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for OV101 to treat Angelman syndrome, a genetic disorder that causes developmental and neurologic disabilities.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
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.
Production & Manufacturing > Process & Production > News
121-135 of 1862 results