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RSS FeedPosted 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 20 Oct 2020
Health Canada has approved Taltz (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis
19 October 2020 - Taltz is now approved to treat patients across the axSpA spectrum, including ankylosing spondylitis and non-radiographic axSpA. ...
Posted by Michael Wonder on 20 Oct 2020
Swissmedic fast-tracks second anti-viral vaccine
19 October 2020 - Swissmedic said the United States pharmaceutical company Pfizer submitted an application for the authorisation of a ...
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
Bristol Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) as second-line treatment for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
16 October 2020 - Application based on Phase 3 ATTRACTION-3 trial demonstrating a statistically significant and clinically meaningful improvement in patients’ ...
Posted by Michael Wonder on 19 Oct 2020
Agios announces withdrawal of European marketing authorisation application for Tibsovo as a treatment for relapsed or refractory IDH1 mutant acute myeloid leukaemia
16 October 2020 - Agios continues to advance two Phase 3 combination trials of Tibsovo in newly diagnosed AML patients. ...
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 19 Oct 2020
EMA virtual conference: 25 years of advancing public and animal health
19 October 2020 - On 22 October 2020, EMA will mark 25 years of its strong commitment to protect public ...
Posted by Michael Wonder on 19 Oct 2020
Janssen receives CHMP positive opinion for expanded use of Tremfya (guselkumab) in the treatment of active psoriatic arthritis in the European Union
16 October 2020 - If approved, guselkumab will be the first selective interleukin 23 p19 sub-unit inhibitor licensed for both ...