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 21 Sep 2022
FDA approves selpercatinib for locally advanced or metastatic RET fusion positive solid tumours
21 September 2022 - Today, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for adult ...
Posted by Michael Wonder on 21 Sep 2022
argenx submits biologics license application to US Food and Drug Administration for subcutaneous efgartigimod for treatment of generalised myasthenia gravis
21 September 2022 - Submission package based on positive data from the Phase 3 ADAPT-SC trial demonstrating non-inferiority of subcutaneous efgartigimod ...
Posted by Michael Wonder on 21 Sep 2022
Guerbet announces US FDA approval of Elucirem (gadopiclenol)
21 September 2022 - FDA approval of Elucirem was granted after priority review, a designation assigned to applications for drugs ...
Posted by Michael Wonder on 21 Sep 2022
Alnylam receives approval in Europe for Amvuttra (vutrisiran) for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy
20 September 2022 - Amvuttra demonstrated halting or reversal in neuropathy impairment with subcutaneous administration once every three months. ...
Posted by Michael Wonder on 21 Sep 2022
Novartis and the pan-Canadian Pharmaceutical Alliance conclude negotiations for Luxturna, a gene therapy for previously untreatable inherited vision loss
20 September 2022 - Novartis Pharmaceuticals Canada and the pan Canadian Pharmaceutical Alliance have successfully concluded negotiations for Luxturna (voretigene neparvovec), ...
Posted by Michael Wonder on 21 Sep 2022
EU health regulator says COVID pandemic not over
20 September 2022 - An official at the European Union's drugs regulator said on Tuesday the COVID-19 pandemic was not ...
Posted by Michael Wonder on 21 Sep 2022
Tezspire approved in the EU for the treatment of severe asthma
21 September 2022 - First and only biologic approved in the EU in patients with severe asthma with no phenotype ...
Posted by Michael Wonder on 21 Sep 2022
Health Canada approves Takeda's Livtencity (maribavir) the first and only treatment for adults with post-transplant cytomegalovirus infection
20 September 2022 - Takeda Canada is pleased to announce that Health Canada has authorized (Notice of Compliance) Livtencity (maribavir) for ...
Posted by Michael Wonder on 21 Sep 2022
TGA provisionally approves Pfizer's COVID-19 vaccine, Comirnaty (tozinameran), for use as a booster dose in individuals 5 years and older
21 September 2022 - On 20 September 2022, the TGA provisionally approved Pfizer's COVID-19 vaccine, Comirnaty (tozinameran) for use as ...
Posted by Michael Wonder on 20 Sep 2022
FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic solid tumours
20 September 2022 - Today, the FDA approved sodium thiosulphate (Pedmark, Fennec Pharmaceuticals) to reduce the risk of ototoxicity associated ...
Posted by Michael Wonder on 20 Sep 2022
Insurer to return $40 million in health care claims to 600,000 Aussies
20 September 2022 - Health insurance company nib is returning $40 million in health care claims to more than 600,000 ...
Posted by Michael Wonder on 20 Sep 2022
UK regulator OKs Celltrion's Avastin biosimilar
19 September 2022 - Celltrion said that the UK's MHRA has approved Vegzelma, a biosimilar referencing Avastin (bevacizumab), to treat ...
Posted by Michael Wonder on 20 Sep 2022
The US Medicaid program: coverage, financing, reforms, and implications for health equity
20 September 2022 - In 2022, Medicaid insured approximately 80.6 million individuals (56.4% from racial and ethnic minority groups in 2019). ...
Posted by Michael Wonder on 20 Sep 2022
Junshi Biosciences receives NMPA approval of sNDA for toripalimab in combination with chemotherapy as first-line treatment for advanced non-squamous non-small-cell lung cancer
20 September 2022 - Sixth approved indication of toripalimab in China, bringing more treatment options to patients with advanced non-small-cell ...
Posted by Michael Wonder on 20 Sep 2022
CHMP adopts positive opinion for Mycapssa for the treatment of acromegaly
16 September 2022 - Positive opinion based on MPOWERED Phase 3 trial. ...