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RSS FeedPosted by Michael Wonder on 05 Aug 2015
UCB announces US and EU regulatory filings for the investigational antiepileptic drug brivaracetam
UCB today announced regulatory milestones in the US and the EU for its investigational antiepileptic drug brivaracetam. In the US, the ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces FDA acceptance of palbociclib new drug application with priority review
Pfizer Inc. today announced the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review ...
Posted by Michael Wonder on 05 Aug 2015
GSK receives FDA approval for Arnuity Ellipta (fluticasone furoate) in the US for the treatment of asthma
GlaxoSmithKline plc today announced that the FDA has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid medicine for maintenance treatment ...
Posted by Michael Wonder on 05 Aug 2015
Novartis submits application to the FDA for meningitis B vaccine candidate Bexsero to help protect US adolescents and young adults
Novartis announced today the submission of a Biologic License Application (BLA) to the US Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves treatment for inhalation anthrax
The U.S. Food and Drug Administration yesterday approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer
The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent ...
Posted by Michael Wonder on 05 Aug 2015
Merck files for FDA approval of Keytruda in lung cancer
Merck & Co Inc said on Sunday it has submitted an application to the U.S. Food and Drug Administration for ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema
The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Technivie for treatment of chronic hepatitis C genotype 4
The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Roche’s Lucentis (ranibizumab injection) for treatment of diabetic retinopathy in people with diabetic macular oedema
Roche announced today that the U.S. Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR), ...
Posted by Michael Wonder on 05 Aug 2015
GSK announces US regulatory submission seeking additional indication for eltrombopag (Promacta)
GSK today announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for ...
Posted by Michael Wonder on 05 Aug 2015
Omeros receives FDA approval of Omidria for use in cataract and other intraocular lens replacement procedures
2 Jun 2014 - Omeros Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Omidria (phenylephrine and ketorolac injection) 1%/0.3% for ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Xtoro to treat swimmer’s ear
The U.S. Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis ...
Posted by Michael Wonder on 05 Aug 2015
Biosimilars guidances
The US FDA has issued a series of guidance documents on the registration/regulation of biosimilar medicines. ...
Posted by Michael Wonder on 05 Aug 2015
Boehringer Ingelheim submits applications for approval of idarucizumab, specific reversal agent to dabigatran etexilate (Pradaxa), to EMA, FDA and Health Canada
Boehringer Ingelheim today announces that idarucizumab has been submitted for approval of marketing authorisation to the European Medicines Agency (EMA), ...