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46-60 of 3532 results
FDA advisory committee recommends Novartis’ CTL019 for r/r B-cell ALL
By PBR Staff Writer
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended Novartis’ CTL019 (tisagenlecleucel) to treat relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
FDA accepts BMS’ sNDA to review Sprycel in Philadelphia CP CML
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) submitted by Bristol-Myers Squibb (BMS) for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase (CP) chronic myeloid leukemia (CML).
Regulatory Affairs > News
Shire submits IND for hemophilia A treatment in US
By PBR Staff Writer
Shire has filed an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for its gene therapy drug, SHP654, to treat hemophilia A.
Regulatory Affairs > News
Japan's MHLW approves Olumiant to treat rheumatoid arthritis
Eli Lilly and Company and Incyte announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.
Regulatory Affairs > News
FDA approves Triptodur to treat central precocious puberty
Arbor Pharmaceuticals and Debiopharm International announced that the US Food and Drug Administration (FDA) has approved Triptodur for the treatment of pediatric patients 2 years and older with central precocious puberty (CPP). CPP occurs when a child shows signs of puberty sooner than normal - before age 8 in girls and 9 nine in boys.
Regulatory Affairs > News
European Commission approves Pfizer's hard-to-treat leukemia drug Besponsa
Pfizer has secured approval from the European Commission for BESPONSA (inotuzumab ozogamicin) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
EC approves expanded use of Novartis’ lung cancer treatment Zykadi
By PBR Staff Writer
Novartis has secured approval from the European Commission (EC) for Zykadi to serve as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive.
Regulatory Affairs > News
FDA takes key steps under new drug competition action plan
By PBR Staff Writer
The US Food and Drug Administration (FDA) is taking two new key steps to increase competition in the market for prescription drugs and support entry of lower-cost alternatives.
Regulatory Affairs > News
Novartis’ etanercept biosimilar approved in Europe to treat inflammatory diseases
By PBR Staff Writer
The European Commission (EC) has approved Novartis’ Erelzi, the biosimilar of Amgen and Pfizer’s Enbrel (etanercept), for the treatment of multiple inflammatory diseases.
Regulatory Affairs > News
Sanofi, Regeneron secure EC approval for Kevzara to treat rheumatoid arthritis
By PBR Staff Writer
Sanofi and Regeneron Pharmaceuticals have secured approval from the European Commission (EC) for Kevzara (sarilumab) in combination with methotrexate (MTX) to treat adult patients with moderately to severely active rheumatoid arthritis (RA) in adult patients.
Regulatory Affairs > News
European Medicines Agency recommends approval of Humira biosimilar Imraldi
By PBR Staff Writer
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis' Imraldi for approval, which is a biosimilar candidate referencing Humira (adalimumab).
Regulatory Affairs > News
Shire gets FDA approval for ADHD drug Mydayis
By PBR Staff Writer
Shire has secured approval from the US Food and Drug Administration (FDA) for its Mydayis (mixed salts of a single-entity amphetamine product) to control attention deficit hyperactivity disorder (ADHD) in patients 13 years and older.
Regulatory Affairs > News
Sandoz gets EC nod for Rixathon to treat blood cancers and immunological diseases
By PBR Staff Writer
Novartis subsidiary Sandoz has secured approval from the European Commission (EC) for its Rixathon (biosimilar rituximab) to treat blood cancers and immunological diseases.
Regulatory Affairs > News
Adamis’ Epinephrine pre-filled syringe secures FDA approval
Adamis Pharmaceuticals’ Epinephrine Injection, USP, 1:1000 (0.3 mg Pre-filled single dose syringe) (“PFS”) has secured approval from the US Food and Drug Administration (FDA) for the emergency treatment of allergic reactions (Type I) including anaphylaxis.
Regulatory Affairs > News
FDA extends Dysport use for lower limb spasticity in adults
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Ipsen’s Dysport (abobotulinumtoxinA) injection to treat lower limb spasticity in adults.
Regulatory Affairs > News
46-60 of 3532 results