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 20 Dec 2020
Hikma launches generic Advair Diskus following FDA approval
17 December 2020 - Hikma Pharmaceuticals announces it has received FDA approval for and launched its generic version of GlaxoSmithKline’s ...
Posted by Michael Wonder on 20 Dec 2020
Swiss to start Pfizer COVID-19 vaccine jabs after watchdog's OK
19 December 2020 - Switzerland will start getting doses of COVID-19 vaccine from Pfizer and partner BioNTech within days after ...
Posted by Michael Wonder on 20 Dec 2020
Lung cancer drug subsidy will make 'big difference' for patients
20 December 2020 - If you’re a non-smoking woman and you develop a cough, the last thing you think you've ...
Posted by Michael Wonder on 19 Dec 2020
Karyopharm announces FDA approval of Xpovio (selinexor) as a treatment for patients with multiple myeloma after at least one prior therapy
18 December 2020 - Oral Xpovio now available as a treatment option for patients with multiple myeloma as early as first ...
Posted by Michael Wonder on 19 Dec 2020
FDA takes additional action in fight against COVID-19 by issuing emergency use authorisation for second COVID-19 vaccine
18 December 2020 - Action follows thorough evaluation of available safety, effectiveness, and manufacturing quality information by FDA career scientists, input ...
Posted by Michael Wonder on 18 Dec 2020
Novartis receives complete response letter from U.S. FDA for inclisiran
18 December 2020 - The U.S. FDA has not raised any concerns related to the efficacy or safety of inclisiran. The ...
Posted by Michael Wonder on 18 Dec 2020
FDA approves first adjuvant therapy for most common type of lung cancer
18 December 2020 - Today, the U.S. FDA approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell ...
Posted by Michael Wonder on 18 Dec 2020
Medicines for hepatitis C remain in the high-cost protection after TLV's reconsideration
18 December 2020 - During the autumn, the Swedish Dental and Pharmaceutical Benefits Agency, TLV, reconsidered the subsidy of the hepatitis ...
Posted by Michael Wonder on 18 Dec 2020
FDA approves first oral hormone therapy for treating advanced prostate cancer
18 December 2020 - Today, the U.S. FDA approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. ...
Posted by Michael Wonder on 18 Dec 2020
Novaremed receives fast track designation from the FDA for NRD135S.E1 for the treatment of painful diabetic peripheral neuropathy
18 December 2020 - Novaremed announced today that it has received fast track designation from the U.S. FDA for the development ...
Posted by Michael Wonder on 18 Dec 2020
Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2.4 mg for weight management
18 December 2020 - Novo Nordisk today announced the submission of a marketing authorisation application to the EMA for subcutaneous semaglutide ...
Posted by Michael Wonder on 18 Dec 2020
Blueprint Medicines submits supplemental new drug application to FDA for Ayvakit (avapritinib) for the treatment of advanced systemic mastocytosis
17 December 2020 - Blueprint Medicines today announced the submission of a supplemental new drug application to the U.S. Food FDA ...
Posted by Michael Wonder on 18 Dec 2020
Recommendations made by the PBAC - November 2020
18 December 2020 - The recommendations from the November 2020 PBAC meeting are now available. ...
Posted by Michael Wonder on 18 Dec 2020
Report on the collection of under co-payment data 2019-20
18 December 2020 - The report on the collection of under co-payment data 2019-20 is now available. ...
Posted by Michael Wonder on 18 Dec 2020
Sandoz Canada receives authorisation from Health Canada to launch new biosimilar Hyrimoz (adalimumab)
17 December 2020 - Hyrimoz approved for use in all same indications as reference medicine* including rheumatology, gastro-enterology and dermatology. ...