Regulatory Affairs

Regulatory Affairs News

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Endo wins preliminary injunction against QuVa in vasopressin case
By PBR Staff Writer
Endo International has won a preliminary injunction in the US, barring QuVa Pharm from introducing a compounding drug that could compete with its Vasostrict, the vasopressin injection indicated to increase blood pressure in adults with vasodilatory shock.
Regulatory Affairs > News
FDA approves Sorrento's non-opioid pain patch for post-herpetic neuralgia
By PBR Staff Writer
Sorrento Therapeutics’ subsidiary Scilex Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for non-opioid ZTlido (lidocaine topical system) 1.8% to relieve pain associated with post-herpetic neuralgia (PHN) or post-shingles pain.
Regulatory Affairs > News
FDA rejects Celgene’s NDA for relapsing multiple sclerosis drug ozanimod
By PBR Staff Writer
The US Food and Drug Administration (FDA) has rejected Celgene’s new drug application (NDA) for relapsing multiple sclerosis drug, ozanimod.
Regulatory Affairs > News
Roche's hemophilia drug Hemlibra secures approval in Europe
By PBR Staff Writer
Roche’s Hemlibra (emicizumab) has been approved by the European Commission (EC) as a prophylactic treatment for bleeding episodes in patients with hemophilia A with factor VIII inhibitors.
Regulatory Affairs > News
FDA grants priority review to Shionogi's lusutrombopag
Shionogi's new drug application (NDA) for lusutrombopag (S-888711) has been accepted for filing and granted priority review by the US Food & Drug Administration (FDA).
Regulatory Affairs > News
Lilly’s breast cancer drug Verzenio secures another approval in US
By PBR Staff Writer
Eli Lilly and Company has secured additional approval from the US Food and Drug Administration (FDA) for Verzenio (abemaciclib) as initial treatment for advanced breast cancer.
Regulatory Affairs > News
FDA accepts Destiny Pharma's IND for XF-73 clinical drug candidate
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Destiny Pharma’s investigational new drug application (IND) for its anti-infective clinical drug candidate, XF-73.
Regulatory Affairs > News
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).
Regulatory Affairs > News
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.
Regulatory Affairs > News
91-105 of 3712 results