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 22 Jun 2021
Nib launches new product providing greater access to unfunded medicines
23 June 2021 - nib New Zealand has launched a new health insurance add-on which provides Kiwis with access to ...
Posted by Michael Wonder on 22 Jun 2021
Update of handbook for companies applying for a subsidy
18 June 2021 - The Swedish Dental and Pharmaceutical Benefits Agency, TLV, has updated parts of the handbook for companies ...
Posted by Michael Wonder on 22 Jun 2021
Acrux receives approval from the FDA for its generic version of Jublia
22 June 2021 - Acrux is pleased to announce that the US FDA has granted approval of the Company’s generic version ...
Posted by Michael Wonder on 22 Jun 2021
HIRA gives Leclaza benefits easily but delays decision on Tagrisso
22 June 2021 - Yuhan's Leclaza (lazertinib), a third-generation treatment for EGFR mutated non-small cell lung cancer, has won the ...
Posted by Michael Wonder on 22 Jun 2021
Medtronic receives FDA expanded approval for Arctic Front family of cardiac cryoablation catheters for initial use for recurrent symptomatic paroxysmal atrial fibrillation
21 June 2021 - First and only approval to indicate cryoablation as an initial rhythm control strategy. ...
Posted by Michael Wonder on 22 Jun 2021
Fennec Pharmaceuticals announces FDA acceptance of new drug application resubmission for Pedmark
22 June 2021 - Prescription Drug User Fee Act target action date set for 27 November 2021. ...
Posted by Michael Wonder on 22 Jun 2021
Proposal for the supply of primidone and gabapentin
22 June 2021 - PHARMAC is seeking additional feedback on a proposal to change the funded brands of primidone tablets ...
Posted by Michael Wonder on 22 Jun 2021
Koselugo approved in the EU for children with neurofibromatosis type 1 and plexiform neurofibromas
22 June 2021 - First medicine approved in the EU to treat this rare and debilitating genetic condition. ...
Posted by Michael Wonder on 22 Jun 2021
Jardiance (empagliflozin) approved in Europe for the treatment of heart failure with reduced ejection fraction
21 June 2021 - This new indication is based on the EMPEROR Reduced trial, which showed a significant 25% reduction in ...
Posted by Michael Wonder on 22 Jun 2021
FDA 'may require' post-marketing studies to analyse long-term effects of breast cancer drugs
21 June 2021 - The US FDA "may require” or seek agreement from sponsors to conduct post-marketing studies to analyse ...
Posted by Michael Wonder on 22 Jun 2021
Bristol Myers Squibb receives European Commission approval for Onureg (azacitidine tablets) as frontline oral maintenance therapy for adults with acute myeloid leukaemia
18 June 2021 - Onureg is the first and only once daily, frontline oral maintenance therapy in the European Union for ...
Posted by Michael Wonder on 21 Jun 2021
Notice of Compliance with Conditions granted for Retevmo (selpercatinib), the first therapy in Canada specifically for patients with advanced RET driven lung and thyroid cancers
21 June 2021 - Conditional marketing authorisation based on data from LIBRETTO-001 Phase 1/2, the largest trial ever reported in patients ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 21 Jun 2021
FDA approves first oral blood thinning medication for children
21 June 2021 - Today, the U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less ...
Posted by Michael Wonder on 21 Jun 2021
EMA publishes agenda for 21-24 June CHMP meeting
21 June 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...