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RSS FeedPosted 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
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
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
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 ...
Posted by Michael Wonder on 04 Feb 2020
Resverlogix receives US FDA breakthrough therapy designation for apabetalone
3 February 2020 - Resverlogix is pleased to announce the U.S. FDA has granted breakthrough therapy designation for apabetalone in combination ...
Posted by Michael Wonder on 04 Feb 2020
Anavex Life Sciences announces fast track designation granted by U.S. FDA for Anavex 2-73 (blarcamesine) clinical development program for the treatment of Rett syndrome
3 February 2020 - Anavex Life Sciences today announced that the U.S. FDA has granted fast track designation for Anavex 2-73 ...
Posted by Michael Wonder on 03 Feb 2020
FDA and FTC announce new efforts to further deter anti-competitive business practices, support competitive market for biological products to help Americans
3 February 2020 - The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding ...
Posted by Michael Wonder on 03 Feb 2020
Arrevus Receives FDA qualified infectious disease product designation for the treatment of cystic fibrosis pulmonary exacerbations
28 January 2020 - Arrevus today announced the U.S. FDA has granted qualified infectious disease product designation for ARV-1801 (sodium ...
Posted by Michael Wonder on 02 Feb 2020
Bayer application for nifurtimox to treat paediatric patients with Chagas disease submitted for approval in US
30 January 2020 - Submission based on results of CHICO (CHagas disease In Children treated with NifurtimOx) phase III clinical study ...
Posted by Michael Wonder on 01 Feb 2020
FDA approves first drug for treatment of peanut allergy for children
31 January 2020 - Today the U.S. Food and Drug Administration approved Palforzia [peanut (arachis hypogaea) allergen powder-dnfp] to mitigate allergic ...
Posted by Michael Wonder on 31 Jan 2020
Pulmatrix receives fast track designation for Pulmazole for the treatment of asthma-ABPA
30 January 2020 - Pulmatrix today announced that the U.S. FDA has granted fast track designation to PUR1900 (Pulmazole), the ...