Regulatory Affairs

Regulatory Affairs News

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Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
Sandoz, a Novartis division, announced that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira.
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Shire’s haemophilia A drug Adynovi secures approval in Europe
The European Commission (EC) has granted marketing authorization for Shire’s Adynovi [Antihemophilic Factor (Recombinant), PEGylated], an extended half-life recombinant factor VIII (rFVIII) treatment, for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
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Midatech gets FDA IND approval to begin trial of brain cancer treatment
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Midatech Pharma’s investigational new drug (IND) application to carry out a study of an investigational nano-inclusion product, MTX110, to treat fatal childhood brain cancer DIPG.
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FDA approves Lynparza in germline BRCA-mutated metastatic breast cancer
AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been earlier treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
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Endo receives subpoena from US Attorney Office on products featuring oxymorphone
Endo International's subsidiary Endo Pharmaceuticals has received a grand jury subpoena from the US Attorney's Office for the Southern District of Florida seeking documents and information relating to products containing oxymorphone.
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FDA panel votes against approval of Lipocine’s testosterone replacement therapy
The US Food and Drug Administration's (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) has decided not to recommend the approval of Lipocine's TLANDO.
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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.
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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.
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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.
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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.
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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).
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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.
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