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16-30 of 3494 results
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
Pfizer, Eli Lilly get FDA fast track status for chronic pain drug Tanezumab
By PBR Staff Writer
Pfizer and Eli Lilly have secured fast track status from the US Food and Drug Administration (FDA) for tanezumab to treat chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP).
Regulatory Affairs > News
FDA asks Endo to withdraw opioid painkiller over abuse risks
By PBR Staff Writer
The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to withdraw its Opana ER (oxymorphone hydrochloride) from the market owing to increased abuse of the reformulated opioid pain medication.
Regulatory Affairs > News
FDA approves two-month dosing option of Alkermes’ Aristada for schizophrenia
By PBR Staff Writer
Alkermes has secured approval from the US Food and Drug Administration (FDA) for a two-month dosing option of Aristada to treat schizophrenia.
Regulatory Affairs > News
ViiV Healthcare seeks EMA, FDA approvals for two-drug regimen to treat HIV-1 infection
By PBR Staff Writer
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer, and Shionogi, is seeking approval from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the HIV maintenance regimen with two medicines.
Regulatory Affairs > News
Pfizer’s Meningococcal Group B vaccine, Trumenba, gets approval in Europe
Pfizer has secured approval the European Commission (EC) for TRUMENBA (Meningococcal Group B Vaccine) for preventing invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MenB) in individuals 10 years of age and older.
Regulatory Affairs > News
FDA panel recommends Pfizer’s epoetin alfa biosimilar to treat anemia
By PBR Staff Writer
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended the approval of Pfizer's biosimilar to Amgen’s anemia drug Epogen (epoetin alfa) across all indications.
Regulatory Affairs > News
FDA approves Merck’s Keytruda for cancer patients with certain biomarkers
The US Food and Drug Administration (FDA) has granted accelerated approval to Merck’s Keytruda for patients whose cancers have a specific genetic feature (biomarker).
Regulatory Affairs > News
UK’s CMA accuses Merck of breaching competition law
The UK’s Competition and Markets Authority (CMA) has issued a statement of objections to pharmaceutical firm Merck Sharp & Dohme Limited (MSD).
Regulatory Affairs > News
16-30 of 3494 results