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RSS FeedPosted by Michael Wonder on 19 Sep 2022
Seagen announces Tukysa (tucatinib) in combination with trastuzumab granted priority review by FDA for previously treated HER2 positive metastatic colorectal cancer
19 September 2022 - FDA has set action date of 19 January 2023 . ...
Posted by Michael Wonder on 19 Sep 2022
FDA grants Radiopharm Theranostics DUNP19 product rare paediatric disease designation
16 September 2022 - Radiopharm Theranostics has been granted rare paediatric disease designation by the US FDA for its DUNP19 ...
Posted by Michael Wonder on 19 Sep 2022
AbbVie secures positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderate to severe Crohn's disease
19 September 2022 - CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one ...
Posted by Michael Wonder on 19 Sep 2022
Ascendis Pharma submits TransCon PTH new drug application to the US FDA for adult patients with hypoparathyroidism
31 August 2022 - European MAA on track for Q4, 2022 submission. ...
Posted by Michael Wonder on 19 Sep 2022
PHARMAC considering multiple new treatments from Takeda
19 September 2022 - Pharmac has initiated consultation today on a provisional bundle deal with Takeda to fund vedolizumab for people ...
Posted by Michael Wonder on 18 Sep 2022
Agios receives positive CHMP opinion for Pyrukynd (mitapivat) for the treatment of pyruvate kinase deficiency in adult patients
16 September 2022 - Agios expects a decision on the marketing authorisation application by the European Commission within 67 days of ...
Posted by Michael Wonder on 17 Sep 2022
Highlights from the 12-15 September 2022 CHMP meeting
16 September 2022 - 12 new medicines recommended for approval. ...
Posted by Michael Wonder on 17 Sep 2022
Swiss regulator gives green light to first drug to prevent Covid-19
16 September 2022 - Swissmedic has issued a temporary marketing authorisation for AstraZeneca’s drug Evusheld, making it the first Covid-19 prophylaxis ...
Posted by Michael Wonder on 17 Sep 2022
ADC Therapeutics and Sobi announce Zylonta (loncastuximab tesirine) receives positive CHMP opinion in Europe for the treatment of relapsed or refractory diffuse large B-cell lymphoma
16 September 2022 - Approval decision expected in 4Q 2022. ...
Posted by Michael Wonder on 17 Sep 2022
Leo Pharma receives positive CHMP opinion of Adtralza (tralokinumab) for the treatment of adolescents with moderate to severe atopic dermatitis
16 September 2022 - Recommendation supported by data from the Phase 3 ECZTRA 6 trial. ...
Posted by Michael Wonder on 17 Sep 2022
CHMP adopts positive opinion to extend indication of Veklury (remdesivir) for the treatment of paediatric patients with COVID-19
16 September 2022 - If granted by the European Commission, Veklury will become the first and only authorised anti-viral treatment for ...
Posted by Michael Wonder on 17 Sep 2022
Heron Therapeutics announces US FDA approval of Aponvie (HTX-019) for the prevention of post-operative nausea and vomiting
16 September 2022 - Aponvie is the first and only intravenous formulation of a substance P/neurokinin-1 receptor antagonist indicated for post-operative ...
Posted by Michael Wonder on 16 Sep 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of COVID-19
16 September 2022 - Recommendation based on TACKLE Phase 3 treatment data showing reduced risk of severe COVID-19 or death. ...
Posted by Michael Wonder on 16 Sep 2022
Prestige BioPharma voluntary withdraws EU license application for Herceptin biosimilar
16 September 2022 - Prestige BioPharma said Thursday it has voluntarily withdrawn its EMA application for the re-examination of approving ...
Posted by Michael Wonder on 16 Sep 2022
CHMP recommends approval of Beyfortus (nirsevimab) for prevention of RSV disease in infants
16 September 2022 - Recommendation is based on the Beyfortus clinical trial program which demonstrated protection against medically attended lower respiratory ...