Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 28 Jun 2021
AstraZeneca available to all Australians; vaccines mandated for quarantine, aged care workers
29 June 2021 - Australians of any age can immediately get the AstraZeneca vaccine if they talk to their GP while ...
Posted by Michael Wonder on 28 Jun 2021
AskBio receives FDA fast track designation for LION-101, a novel investigational AAV gene therapy for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)
28 June 2021 - LGMD2I/R9 is a rare form of muscular dystrophy with no approved therapies. ...
Posted by Michael Wonder on 28 Jun 2021
SNDX-5613 granted FDA fast track designation for the treatment of relapsed/refractory acute leukemias
28 June 2021 - Syndax Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to SNDX-5613 for the ...
Posted by Michael Wonder on 28 Jun 2021
Technegas receives complete response letter from the US FDA - requirement to address outstanding technical elements
28 June 2021 - Cyclopharm announces that the US FDA has provided a complete response letter for the new drug application ...
Posted by Michael Wonder on 28 Jun 2021
InnoCare announces breakthrough therapy designation of orelabrutinib by US FDA for treatment of relapsed or refractory mantle cell lymphoma
28 June 2021 - InnoCare Pharma announced today that the U.S. FDA has granted breakthrough therapy designation to its Bruton's ...
Posted by Michael Wonder on 28 Jun 2021
Success rate for marketing authorisation applications from SMEs doubles between 2016 and 2020
28 June 2021 - EMA has published today a report highlighting the Agency’s support for micro, small and medium sized ...
Posted by Michael Wonder on 28 Jun 2021
UCB receives positive CHMP opinion recommending approval of Bimzelx (bimekizumab) in the EU for the treatment of adults with moderate to severe plaque psoriasis
25 June 2021 - The positive CHMP opinion is supported by data from three Phase 3 trials where bimekizumab demonstrated superior ...
Posted by Michael Wonder on 28 Jun 2021
Incyte and MorphoSys announce positive CHMP opinion for tafasitamab in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
25 June 2021 - The positive opinion from the CHMP is based on data from the Phase 2 L-MIND study evaluating ...
Posted by Michael Wonder on 28 Jun 2021
Astellas receives positive CHMP opinion for Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
25 June 2021 - Astellas Pharma today announced the CHMP of the EMA has adopted a positive opinion relating to the ...
Posted by Michael Wonder on 28 Jun 2021
Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease
26 June 2021 - If approved, Forxiga has the potential to change the treatment paradigm for millions of people in ...
Posted by Michael Wonder on 28 Jun 2021
Eagle Pharmaceuticals announces FDA maintains prioritisation of ANDA for vasopressin
24 June 2021 - Assigned GDUFA date of 15 December 2021, and expects commercial launch prior to year-end. ...
Posted by Michael Wonder on 28 Jun 2021
Bristol Myers Squibb receives positive CHMP opinion for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
25 June 2021 - Recommendation based on positive results from the Phase 3 CheckMate -577 trial in which Opdivo doubled disease-free ...
Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy indicated for patients with advanced basal cell carcinoma
25 June 2021 - Approval based on data from the largest trial to date in patients with advanced basal cell carcinoma ...
Posted by Michael Wonder on 28 Jun 2021
Libtayo (cemiplimab) approved by the European Commission for first-line treatment of patients with advanced non-small cell lung cancer with ≥50% PD-L1 expression
25 June 2021 - Approval based on a Phase 3 trial demonstrating Libtayo significantly improved overall survival compared to chemotherapy in ...
Posted by Michael Wonder on 28 Jun 2021
COVID-19 vaccine weekly safety report (24 June 2021)
24 June 2021 - Five additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...