Regulatory Affairs

Regulatory Affairs News

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AstraZeneca’s Fasenra gets approval in Europe for severe eosinophilic asthma
By PBR Staff Writer
AstraZeneca has secured approval from the European Commission (EC) for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe eosinophilic asthma.
Regulatory Affairs > News
Lipocine Announces Outcome of FDA Advisory Committee Meeting for TLANDO, Testosterone Replacement Therapy in Adult Males with Hypogonadism
Lipocine Inc., a specialty pharmaceutical company, announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of TLANDO, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
Regulatory Affairs > News
AbbVie’s Upadacitinib gets FDA breakthrough designation for atopic dermatitis
AbbVie’s investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Regulatory Affairs > News
FDA expands use of Amgen's XGEVA drug
Amgen has secured approval from the US Food and Drug Administration (FDA) for its supplemental biologics license application (sBLA) of XGEVA (denosumab) to expand the currently approved indication to prevent skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
Regulatory Affairs > News
Novartis’ Promacta gets FDA breakthrough designation for severe aplastic anemia
By PBR Staff Writer
Novartis’ drug Promacta (eltrombopag) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for first-line treatment of severe aplastic anemia (SAA).
Regulatory Affairs > News
Cantex's CX-01 gets FDA orphan drug status to treat acute myeloid leukemia
Cantex Pharmaceuticals has secured orphan drug designation from the US Food and Drug Administration (FDA) for CX-01 to treat acute myeloid leukemia (AML).
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Seattle Genetics’ Adcetris gets FDA priority review for Hodgkin lymphoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review to a Seattle Genetics’ supplemental biologics license application (BLA) that seeks approval of (brentuximab vedotin) in combination with chemotherapy in combination with chemotherapy for the frontline treatment of advanced classical Hodgkin lymphoma.
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Mylan launches Estrace Cream generic after FDA approval
Mylan has launched Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace Cream, in the US.
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Roche secures cancer drug approvals in Europe and US
By PBR Staff Writer
Switzerland-based drug manufacturer Roche has secured approvals for two cancer drugs in Europe and the US.
Regulatory Affairs > News
Spark’s gene therapy Luxturna secures FDA approval for rare form of blindness
By PBR Staff Writer
Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec) has been approved by the US Food and Drug Administration (FDA) for the treatment of children and adults having a rare inherited form of vision loss that could lead to blindness.
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Alnylam, Sanofi submit MAA to EMA for patisiran to treat hereditary ATTR amyloidosis
Alnylam Pharmaceuticals and Sanofi Genzyme have submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
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FDA proposes risk-based enforcement approach to homeopathic drugs
By PBR Staff Writer
The US Food and Drug Administration (FDA) is proposing new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.
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Aclaris gets FDA nod for Eskata drug to treat raised seborrheic keratoses
Aclaris Therapeutics has secured approval from the US Food and Drug Administration (FDA) for Eskata (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses or SKs.
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Shire gets EC nod for lyophilized Oncaspar to treat acute lymphoblastic leukemia
By PBR Staff Writer
Shire has secured marketing approval from the European Commission (EC) for new formulation of Oncaspar to treat patients with acute lymphoblastic leukemia (ALL).
Regulatory Affairs > News
Sanofi’s Admelog (insulin lispro injection) gets FDA approval to treat diabetes
By PBR Staff Writer
Sanofi’s Admelog (insulin lispro injection) has been approved by the US Food and Drug Administration (FDA) to help diabetic patients control their blood sugar levels at mealtime.
Regulatory Affairs > News
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