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 15 May 2026
SMC - May 2026 decisions
11 May 2026 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland, has today ...
Posted by Michael Wonder on 15 May 2026
Wegovy and Mounjaro for weight loss not funded
14 May 2026 - PHARMAC has assessed the application to fund Wegovy for weight loss and added it to our ...
Posted by Michael Wonder on 15 May 2026
Apotex launches Apo‑Semaglutide Injection, a generic equivalent of Ozempic, in Canada
14 May 2026 - Apotex today announced the commercial launch of Apo‑Semaglutide Injection – a generic equivalent of Ozempic. ...
Posted by Michael Wonder on 15 May 2026
Routine NHS access to spinal muscular atrophy treatments offers new hope for patients and families
14 May 2026 - People living with spinal muscular atrophy in England are set to gain routine access to two potentially ...
Posted by Michael Wonder on 15 May 2026
Over 1,500 people set to benefit from first immunotherapy for aggressive stomach cancer
14 May 2026 - Over 1,500 people set to benefit from first immunotherapy for aggressive stomach cancer. ...
Posted by Michael Wonder on 15 May 2026
INmune Bio receives FDA fast track designation for XPro1595 in early Alzheimer's disease
14 May 2025 - INmune Bio today announced that the US FDA has granted fast track designation to XPro (pegipanermin), the ...
Posted by Michael Wonder on 13 May 2026
FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
13 May 2026 - Today, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology) with ...
Posted by Michael Wonder on 13 May 2026
FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
13 May 2026 - Today, the FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines), a BCL-2 inhibitor, for adults ...
Posted by Michael Wonder on 13 May 2026
European Commission approves Pfizer’s Hympavzi for the treatment of adults and adolescents with haemophilia A or B with inhibitors
13 May 2026 - Pfizer today announced that the European Commission has granted marketing authorisation to expand the approved indication ...
Posted by Michael Wonder on 13 May 2026
Kyverna Therapeutics announces initiation of rolling SPS BLA submission
12 May 2026 - The Company has initiated its rolling BLA submission, seeking priority review under the program's regenerative medicine advanced ...
Posted by Michael Wonder on 13 May 2026
BridgeBio submits NDA to FDA for encaleret for individuals living with ADH1
12 May 2026 - BridgeBio Pharma today announced the submission of its new drug application to the FDA for encaleret as ...
Posted by Michael Wonder on 13 May 2026
Agios submits sNDA to FDA for US accelerated approval of mitapivat in sickle cell disease
12 May 2026 - Agios Pharmaceuticals today announced the submission of its supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 12 May 2026
Coya Therapeutics has been granted US FDA fast track designation for COYA 302 for the treatment of amyotrophic lateral sclerosis
12 May 2026 - Coya Therapeutics today announced that the US FDA has granted fast track designation for COYA 302, ...
Posted by Michael Wonder on 12 May 2026
Emiltatug ledadotin granted breakthrough therapy designation by the US FDA for adenoid cystic carcinoma
12 May 2026 - Servier today announced that the US FDA has granted breakthrough therapy designation to emiltatug ledadotin, an investigational ...
Posted by Michael Wonder on 12 May 2026
FDA advances drug repurposing to address unmet medical needs
11 May 2026 - Agency is particularly focused on new uses to treat chronic or rare diseases. ...