Regulatory Affairs

Regulatory Affairs News

View news from other Pharmaceutical sectors:
106-120 of 3712 results
Janssen’s Erleada wins FDA nod for nonmetastatic prostate cancer
By PBR Staff Writer
Janssen Pharmaceutical’s androgen receptor inhibitor Erleada (apalutamide) has been approved by the US Food and Drug Administration (FDA) for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC).
Regulatory Affairs > News
Novartis secures FDA approval for larger dosage of MS drug Glatopa
By PBR Staff Writer
Novartis’ Sandoz division has secured approval from the US Food and Drug Administration (FDA) for a larger dosage of its Glatopa drug to treat relapsing forms of multiple sclerosis (MS).
Regulatory Affairs > News
UK’s NICE recommends Eusa Pharma’s Fotivda to treat advanced renal cell carcinoma
By PBR Staff Writer
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Eusa Pharma’s Fotivda (tivozanib) as a first line treatment for adult patients with advanced renal cell carcinoma (aRCC).
Regulatory Affairs > News
Vertex’s Symdeko cystic fibrosis drug secures FDA approval
By PBR Staff Writer
Vertex Pharmaceuticals’ Symdeko (tezacaftor/ivacaftor and ivacaftor) has been approved in the US to treat the underlying cause of cystic fibrosis (CF) in people aged 12 and over.
Regulatory Affairs > News
Novo Nordisk’s Ozempic secures European approval for type 2 diabetes
Novo Nordisk’s Ozempic (semaglutide) has secured marketing authorization from the European Commission (EC) for the treatment of adults with type 2 diabetes.
Regulatory Affairs > News
Novartis' Cosentyx label expanded to include scalp psoriasis
Novartis has secured approval from the US Food and Drug Administration (FDA) for Cosentyx (secukinumab) label update to include moderate-to-severe scalp psoriasis.
Regulatory Affairs > News
ViiV Healthcare sues Gilead over HIV drug patent infringement
By PBR Staff Writer
ViiV Healthcare has filed a lawsuit against Gilead Sciences alleging that bictegravir contained in the latter’s triple combination HIV drug infringes patent covering dolutegravir in the US and Canada.
Regulatory Affairs > News
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).
Regulatory Affairs > News
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.
Regulatory Affairs > News
106-120 of 3712 results