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RSS FeedPosted 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 ...
Posted by Michael Wonder on 19 Oct 2020
Aimmune receives positive CHMP opinion on Palforzia for the treatment of patients with peanut allergy in Europe
16 October 2020 - Final European Commission Decision on Marketing Approval Anticipated in Q4 2020. ...
Posted by Michael Wonder on 19 Oct 2020
Forxiga recommended for approval in the EU by CHMP for heart failure
19 October 2020 - If approved, Forxiga would become the first SGLT2 inhibitor indicated for heart failure with reduced ejection ...
Posted by Michael Wonder on 19 Oct 2020
Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD
19 October 2020 - Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials ...
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 18 Oct 2020
Highlights from 12-15 October CHMP meeting
16 October 2020 - Ten new medicines recommended for approval. ...
Posted by Michael Wonder on 18 Oct 2020
Novartis receives positive CHMP opinion for Leqvio (inclisiran), a potential first-in-class siRNA for the treatment of high cholesterol
16 October 2020 - If approved, inclisiran will be the first and only small interfering RNA (siRNA) in Europe for patients ...