Regulatory Affairs

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Shield receives CHMP positive opinion for Feraccru to treat iron deficiency in adults
Shield Therapeutics announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation approval of Feraccru (Ferric Maltol) to be extended to include treatment of all adults with iron deficiency (ID) with or without anaemia.
Regulatory Affairs > News
Diurnal secures patents for Alkindi and Chronocort in Japan
Diurnal Group, a specialty pharmaceutical company focused on developing treatments for chronic endocrine (hormonal) diseases, has secured patents from the Japanese Patent Office (JPO) for Alkindi (Infacort) and Chronocort.
Regulatory Affairs > News
FDA approves KemPharm’s Apadaz for short-term pain management
By PBR Staff Writer
KemPharm has secured approval from the US Food and Drug Administration (FDA) for its opioid painkiller, Apadaz, for the short-term management of acute pain.
Regulatory Affairs > News
FDA accepts Acorda’s NDA for orally inhaled levodopa therapy Inbrija
The US Food and Drug Administration (FDA) has accepted for filing Acorda Therapeutics' new drug application (NDA) for Inbrija (levodopa inhalation powder).
Regulatory Affairs > News
Mylan bags FDA’s tentative approval for fixed-dose HIV combo therapy
By PBR Staff Writer
Mylan has secured tentative approval from the US Food and Drug Administration (FDA) for its fixed-dose HIV combination therapy Dolutegravir/Emtricitabine/Tenofovir Alafenamide (DTG/FTC/TAF 50 mg/200mg/25mg) tablets.
Regulatory Affairs > News
AstraZeneca's Imfinzi wins FDA approval for lung cancer treatment
By PBR Staff Writer
AstraZeneca's immunotherapy Imfinzi (durvalumab) has secured approval from the US Food and Drug Administration (FDA) for unresectable stage III non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
FDA grants orphan drug designation to Selumetinib for neurofibromatosis type 1
AstraZeneca and Merck said that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).
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GSK’s Fluarix Tetra wins European approval for expanded indication
GSK has secured European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older.
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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).
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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
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