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RSS FeedPosted by Michael Wonder on 07 Feb 2020
Revance announces U.S. FDA acceptance of biologics license application for DAXI to treat glabellar (frown) lines
6 February 2020 - Prescription Drug User Fee Act target action date of 25 November 2020. ...
Posted by Michael Wonder on 07 Feb 2020
Blueprint Medicines announces PDUFA date extension for new drug application of avapritinib for the treatment of adults with fourth-line gastro-intestinal stromal tumour
6 February 2020 - PDUFA action date extended by three months to 14 May 2020. ...
Posted by Michael Wonder on 05 Feb 2020
Alector announces FDA fast track designation granted to AL101 for the treatment of patients with frontotemporal dementia
5 February 2020 - Alector today announced that the U.S. FDA has granted fast track designation to AL101 for the treatment ...
Posted by Michael Wonder on 05 Feb 2020
Orsini Pharmaceutical Services now providing FDA approved Vyondys 53 (golodirsen) injection for Duchenne muscular dystrophy
5 February 2020 - Commercial distribution of Vyondys 53 in the U.S. is currently underway. ...
Posted by Michael Wonder on 05 Feb 2020
WPD Pharmaceuticals’ annamycin drug received FDA approval of fast track designation
5 February 2020 - WPD Pharmaceuticals is pleased to provide an update on its annamycin drug. ...
Posted by Michael Wonder on 05 Feb 2020
Merck receives approval for Belsomra (suvorexant) C-IV label update to include findings from study of insomnia in patients with mild-to-moderate Alzheimer’s disease
3 February 2020 - Merck today announced that the company has received approval from the U.S. FDA for an update to ...
Posted by Michael Wonder on 05 Feb 2020
FDA takes significant step in coronavirus response efforts, issues emergency use authorisation for the first 2019 novel coronavirus diagnostic
4 February 2020 - Critical milestone reached in response to this outbreak. ...
Posted by Michael Wonder on 05 Feb 2020
EMA to support development of vaccines and treatments for novel coronavirus
4 February 2020 - To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA ...
Posted by Michael Wonder on 05 Feb 2020
Mesoblast submits completed biologics license application for Ryoncil to US FDA
3 February 2020 - Mesoblast today announced that it has submitted its completed niologics license application to the US FDA ...
Posted by Michael Wonder on 04 Feb 2020
EU flags are up in EMA’s new building in Amsterdam
3 February 2020 - EMA’s staff gathered today to raise the EU flags in the lobby of its new and ...
Posted by Michael Wonder on 04 Feb 2020
GW Pharmaceuticals and Greenwich Biosciences submit supplemental new drug application to U.S. FDA for Epidiolex (cannabidiol) for the treatment of tuberous sclerosis complex
3 February 2020 - GW Pharmaceuticals announced today that it has submitted a supplemental new drug application to the U.S. FDA ...
Posted by Michael Wonder on 04 Feb 2020
TherapeuticsMD announces submission of new drug application prior approval efficacy supplement to the U.S. FDA for lower dose of Bijuva
3 February 2020 - TherapeuticsMD announced today that it submitted a new drug application prior-approval efficacy supplement for Bijuva 0.5 ...
Posted by Michael Wonder on 04 Feb 2020
FDA accepts for review supplemental new drug application for Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia
3 February 2020 - Filing receives priority review. ...
Posted by Michael Wonder on 04 Feb 2020
Rybelsus (oral semaglutide) recommended for approval for the treatment of adults with type 2 diabetes by the European regulatory authorities
31 January 2020 - Novo Nordisk today announced that the CHMP under the EMA has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 04 Feb 2020
Seqirus announces U.S. FDA approval of its first-ever adjuvanted, cell-based pandemic influenza A (H5N1) vaccine
3 February 2020 - Seqirus, a global leader in influenza prevention and pandemic response, today announced that the U.S. FDA ...