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RSS FeedPosted by Michael Wonder on 21 Oct 2020
Selecta Biosciences and AskBio receive FDA rare paediatric disease designation for their gene therapy for methylmalonic acidemia
20 October 2020 - Selecta Biosciences and Asklepios BioPharmaceutical today announced the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 21 Oct 2020
California plans to review coronavirus vaccine independently
19 October 2020 - California is planning to review federally approved coronavirus vaccines independently before distributing it to residents, Governor ...
Posted by Michael Wonder on 20 Oct 2020
COVID-19 vaccines: time to talk about the uncertainties
20 October 2020 - Plan now for decisions on which vaccines should go to whom, when and how often. ...
Posted by Michael Wonder on 20 Oct 2020
Roche CEO warns against high hopes for speedy Covid vaccines
20 October 2020 - Many people’s hopes for a speedy coronavirus vaccine are still too high, Roche Holding AG Chief ...
Posted by Michael Wonder on 20 Oct 2020
Tagrisso granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer
20 October 2020 - Unprecedented results show treatment with Tagrisso reduced the risk of disease recurrence or death by 80% in ...
Posted by Michael Wonder on 19 Oct 2020
All eyes on a hurdle race for a SARS-CoV-2 vaccine
19 October 2020 - Leading COVID-19 vaccine candidates have progressed through laboratory tests at record speed. ...
Posted by Michael Wonder on 19 Oct 2020
Glenmark Pharmaceuticals receives ANDA approval for sirolimus 0.5 mg, 1 mg and 2 mg tablets
19 October 2020 - Glenmark Pharmaceuticals has received final approval by the United States FDA for sirolimus 0.5 mg, 1 mg ...
Posted by Michael Wonder on 19 Oct 2020
Inventiva receives FDA fast track designation in MPS VI for its clinical-stage asset odiparcil
19 October 2020 - Inventiva today announced that the U.S. FDA has granted fast track designation to odiparcil, the Company’s clinical-stage ...
Posted by Michael Wonder on 19 Oct 2020
Octapharma announces FDA approval of updated Nuwiq Prescribing Information to include immunogenicity data in previously untreated patients
19 October 2020 - Octapharma is pleased to announce that the U.S. FDA has approved an updated Prescribing Information for Nuwiq, ...
Posted by Michael Wonder on 19 Oct 2020
Neurelis announces FDA approval of extended expiration dating for Valtoco (diazepam nasal spray)
19 October 2020 - Neurelis today that the U.S. FDA has granted extended expiration dating for the company's lead product, Valtoco ...
Posted by Michael Wonder on 19 Oct 2020
U.S. Food and Drug Administration accepts for priority review applications for Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in advanced renal cell carcinoma
19 October 2020 - U.S. Food and Drug Administration assigned a target action date of 20 February 2021. ...
Posted by Michael Wonder on 19 Oct 2020
Versantis receives FDA rare paediatric disease designation for VS-01 for the treatment of urea cycle disorders
19 October 2020 - Versantis today announced that the U.S. FDA has granted a rare paediatric disease designation to its lead ...
Posted by Michael Wonder on 19 Oct 2020
AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) in atopic dermatitis
19 October 2020 - In three pivotal Phase 3 studies, Rinvoq met co-primary and all secondary endpoints in adult and adolescent ...
Posted by Michael Wonder on 18 Oct 2020
Pfizer to seek FDA approval for COVID-19 vaccine in November
16 October 2020 - US group and German partner BioNTech prepare to submit trial results next month. ...
Posted by Michael Wonder on 17 Oct 2020
Venclexta (venetoclax) receives FDA full approval for acute myeloid leukaemia
16 October 2020 - The FDA approval of Venclexta for newly diagnosed AML patients who are ineligible for intensive chemotherapy is ...