Regulatory Affairs

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Gilead’s Biktarvy triple HIV drug secures FDA approval
By PBR Staff Writer
Gilead Sciences has secured approval from the US Food and Drug Administration (FDA) for Biktarvy, a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
Regulatory Affairs > News
Zogenix secures FDA breakthrough therapy designation for ZX008 in Dravet syndrome
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Zogenix’s investigational product, ZX008 (low-dose fenfluramine), for the treatment of seizures associated with Dravet syndrome.
Regulatory Affairs > News
Capricor gets FDA RMAT designation for CAP-1002 to treat Duchenne muscular dystrophy therapy
The US Food and Drug Administration (FDA) has granted the regenerative medicine advanced therapy (RMAT) designation for Capricor Therapeutics’ investigational cell therapy for the treatment, CAP-1002, to treat Duchenne muscular dystrophy.
Regulatory Affairs > News
FDA approves Avycaz to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
The US Food and Drug Administration (FDA) has approved Allergan's supplemental new drug application (sNDA) to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
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Amgen receives CHMP positive opinion to add updated overall survival data to Kyprolis label
Amgen has received a positive opinion from the Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to add updated overall survival data to Kyprolis label.
Regulatory Affairs > News
FDA grants fast track status to Takeda’s Zika virus vaccine candidate
By PBR Staff Writer
Takeda Pharmaceutical has secured fast track designation from the US Food and Drug Administration (FDA) for its Zika virus vaccine candidate, TAK-426.
Regulatory Affairs > News
FDA approves Advanced Accelerator's Lutathera for certain digestive tract cancers
By PBR Staff Writer
Advanced Accelerator Applications’ radioactive drug Lutathera (lutetium Lu 177 dotatate) has been approved by the US Food and Drug Administration (FDA) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Regulatory Affairs > News
Shire secures FDA approval for technology transfer of Cinryze manufacturing process
Shire said that the US Food and Drug Administration has approved the technology transfer of Cinryze (C1 esterase inhibitor [human]) drug product manufacturing process to its Vienna, Austria manufacturing site.
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Astellas’ gilteritinib gets orphan designation in Europe for acute myeloid leukaemia
Astellas Pharma's gilteritinib has secured orphan designation from the European Commission (EC) to treat patients with acute myeloid leukaemia (AML).
Regulatory Affairs > News
Sobi’s metabolic disorder drug secures fast track status in US
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Swedish Orphan Biovitrum's (Sobi) new drug application and granted fast track status for mucopolysaccharidosis type IIIA (MPS IIIA) drug candidate SOBI003.
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Bristol-Myers’ Yervoy approved in Europe for pediatric melanoma
The European Commission (EC) has approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for the treatment of pediatric patients 12 years and older with unresectable or metastatic melanoma.
Regulatory Affairs > News
FDA grants priority review for daratumumab in front line multiple myeloma
Genmab announced that the US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib, melphalan and prednisone to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
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AstraZeneca secures approvals for cancer and asthma drugs in Japan
By PBR Staff Writer
AstraZeneca has secured approvals for its cancer drug Lynparza (olaparib) and asthma drug Fasenra (benralizumab) from the Japanese Ministry of Health, Labour and Welfare for the treatments of ovarian cancer and bronchial asthma, respectively.
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USPTO invalidates J&J’s patent on prostate cancer drug Zytiga
By PBR Staff Writer
The US Patent & Trademark Office (USPTO) has invalidated a Johnson & Johnson (J&J) patent on prostate cancer drug Zytiga (abiraterone acetate).
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Novartis’ Kymriah nabs speedy reviews in US, Europe for lymphoma treatment
By PBR Staff Writer
Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) has been granted fast-tracked reviews in the US and Europe for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
Regulatory Affairs > News
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