Regulatory Affairs

Regulatory Affairs News

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EMA to review cemiplimab for treatment of advanced cutaneous squamous cell carcinoma
The European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.
Regulatory Affairs > News
US and European regulators accept AstraZeneca’s applications for cancer treatments
By PBR Staff Writer
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted AstraZeneca’s applications for cancer treatments moxetumomab pasudotox and Lynparza (olaparib).
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FDA rejects Alkermes’ NDA for antidepressant drug
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Alkermes’ new drug application (NDA) for antidepressant drug, ALKS 5461.
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FDA approves new indication for Amgen’s leukemia drug Blincyto
The US Food and Drug Administration (FDA) has approved Amgen’s supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission in adults and children.
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Daiichi Sankyo’s DS-8201 gets SAKIGAKE designation in Japan for gastric cancer
The Japan Ministry of Health, Labour and Welfare (MHLW) has granted SAKIGAKE Designation to Daiichi Sankyo’s investigational HER2-targeting antibody drug conjugate (ADC) DS-8201 for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer.
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Fennec Pharmaceuticals' Pedmark gets FDA breakthrough status
By PBR Staff Writer
Fennec Pharmaceuticals has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for Pedmark to prevent cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB).
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Seattle Genetics, Astellas get FDA breakthrough therapy designation for enfortumab vedotin locally advanced or metastatic urothelial cancer
Seattle Genetics, and Astellas Pharma have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for enfortumab vedotin, an antibody-drug conjugate (ADC), to treat patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).
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Soligenix gets orphan drug designation from European Commission for RiVax to prevent Ricin poisoning
The European Commission has granted orphan drug designation to the Soligenix recombinant modified ricin toxin A-chain subunit (the active pharmaceutical ingredient in RiVax) for the prevention of ricin poisoning.
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FDA expands approval for Novartis’ Tasigna to treat children with rare form of leukemia
The US Food and Drug Administration (FDA) has expanded the indication for Novartis’ Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
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Sun Pharma gets FDA nod for Ilumya to treat moderate-to-severe plaque psoriasis
By PBR Staff Writer
India-based Sun Pharma has secured approval from the US Food and Drug Administration (FDA) for Ilumya (tildrakizumab-asmn) to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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FDA expands approval of Seattle Genetics’ Adcetris for advanced classical Hodgkin Lymphoma
By PBR Staff Writer
Seattle Genetics’ Adcetris (Brentuximab Vedotin) in combination with chemotherapy has been approved by the US Food and Drug Administration (FDA) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL).
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FDA grants Xtandi priority review for Nonmetastatic CRPC
The US Food and Drug Administration (FDA) has accepted Pfizer and Astellas Pharma's supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for a new indication and granted priority review designation.
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FDA approves Hizentra to treat chronic inflammatory demyelinating polyneuropathy
The US Food and Drug Administration (FDA) has approved CSL Behring’s Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
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Destiny Pharma's XF-73 MRSA drug gets FDA fast track designation
Destiny Pharma’s has secured fast track designation from the US Food and Drug Administration (FDA) for its lead clinical candidate exeporfinium chloride (XF-73) for the prevention of post-surgical staphylococcal infections such as Methicillin Resistant Staphylococcus aureus (MRSA).
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Proteostasis' PTI-428 gets FDA orphan drug designation to treat cystic fibrosis
Proteostasis Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its PTI-428, which is a cystic fibrosis transmembrane conductance regulator (CFTR) amplifier drug candidate.
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