• Facebook
  • Twitter
  • LinkedIn
  • Google +
  • RSS

US Food and Drug Administration (FDA) - Articles and news items

FDA takes action against 14 companies for selling illegal cancer treatments

Industry news / 26 April 2017 / Niamh Marriott, Junior Editor

The FDA posted warning letters to 14 US-based companies illegally selling over 65 products that fraudulently claim to prevent, treat or cure cancer…

CPhI expert says quicker approvals for ANDA’s would lower drug costs

Industry news / 26 April 2017 / Niamh Marriott, Junior Editor

Girish Malhotra argues time reduction for ANDA approvals, arguing that if the current approval time can be reduced, drug costs will decrease…

BioMarin receives positive CHMP opinion for fatal brain disorder treatment in children

Industry news / 26 April 2017 / Niamh Marriott, Junior Editor

CHMP has adopted a positive opinion for the company’s MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease…

compassionate

FDA allows novel inhaled lung cancer treatment to commence clinical trials

Industry news / 25 April 2017 / Niamh Marriott, Junior Editor

North Carolina based Biomarck Pharmaceuticals has received FDA allowance to begin human trials for their patented compound BIO-11006, for adults with lung cancer.

AbbVie’s HCV/ compensated cirrhosis drug achieved 99% SVR12 rate

Industry news / 24 April 2017 / Niamh Marriott, Junior Editor

AbbVie announced that 99% (145/146) of chronic hepatitis C virus (HCV) infected patients with genotype and compensated cirrhosis (Child-Pugh A)…

Novartis expands development programs for NASH with Allergan clinical partnership

Industry news / 20 April 2017 / Niamh Marriott, Junior Editor

Novartis has entered into a clinical trial agreement with Allergan to conduct a Phase IIb study, involving the combination of a Novartis’ FXR agonist…

Novartis’ lymphoma treatment receives FDA breakthrough therapy designation

Industry news / 19 April 2017 / Niamh Marriott, Junior Editor

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis’ CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. This is the second indication for which […]

designation

Enzyvant receives FDA designation for investigational therapy

Industry news / 19 April 2017 / Niamh Marriott, Junior Editor

The US Food and Drug Administration (FDA) has granted Enzyvant’s RVT-802, an investigational tissue-based therapy for the treatment of complete DiGeorge Syndrome (cDGS), breakthrough therapy designation as well as regenerative medicine advanced therapy (RMAT) designation. Both designations confer special access to the Office of Tissues and Advanced Therapies for development guidance as well as expedited […]

immune thrombocytopenia

Rigel submits new drug application to FDA for Fostamatinib in Chronic ITP

Industry news / 18 April 2017 / Niamh Marriott, Junior Editor

Rigel Pharmaceuticals has submitted a new drug application to the US FDA for fostamatinib in patients with immune thrombocytopenia…

FDA approves first drug to treat tardive dyskinesia

Industry news / 12 April 2017 / Niamh Marriott, Junior Editor

The US Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.   Tardive dyskinesia is a neurological disorder characterised by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue […]

Jazz Pharmaceuticals submits FDA application for leukaemia treatment

Industry news / 7 April 2017 / Niamh Marriott, Junior Editor

Jazz Pharmaceuticals completed a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of Vyxeos…

waiver

FDA grants Kitov waiver for new drug application filing fee

Industry news / 6 April 2017 / Niamh Marriott, Junior Editor

The US Food and Drug Administration (FDA) has granted Kitov Pharmaceuticals a waiver related to the $2,038,100 new drug application filing fee for KIT-302…