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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 17 Jan 2026
Fondazione Telethon receives european marketing authorisation for Waskyra (etuvetidigene autotemcel), a gene therapy for the treatment of Wiskott-Aldrich syndrome
16 January 2026 - The European Commission’s decision follows the positive opinion issued by the EMA’s CHMP in November 2025. ...
Posted by Michael Wonder on 17 Jan 2026
Novartis ianalumab receives FDA breakthrough therapy designation for Sjögren’s disease
16 January 2026 - Novartis today announced that the US FDA has granted breakthrough therapy designation to ianalumab for Sjögren’s disease, ...
Posted by Michael Wonder on 17 Jan 2026
Human medicines in 2025
15 January 2026 - In 2025, the EMA recommended 104 medicines for marketing authorisation. ...
Posted by Michael Wonder on 16 Jan 2026
FDA reports lack of interest, high rejection rate for its STAR program
15 January 2026 - The US FDA said there is "minimal industry interest" from companies to participate in its Split ...
Posted by Michael Wonder on 16 Jan 2026
Guiding principles of good AI practice in drug development
14 January 2026 - The CDER and CBER have collaborated with the EMA to develop 10 guiding principles that industry ...
Posted by Michael Wonder on 16 Jan 2026
Santhera receives Swissmedic approval of Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy
15 January 2026 - Commercial launch in Switzerland anticipated in H2, 2026. ...
Posted by Michael Wonder on 16 Jan 2026
Inside a clinic as Alzheimer’s patients and families gamble on controversial and costly new drugs
16 January 2026 - What price would you pay for the chance of just a little more quality time with a ...
Posted by Michael Wonder on 16 Jan 2026
FDA issues guidance on modernising statistical methods for clinical trials
12 January 2026 - The US FDA today published draft guidance designed to facilitate the use of Bayesian methodologies in ...
Posted by Michael Wonder on 15 Jan 2026
PBS prescription medicines more affordable for Australians
13 January 2026 - The Australian Government has launched a new advertising campaign to raise awareness about changes to maximum patient ...
Posted by Michael Wonder on 15 Jan 2026
Ontario pioneers access to treatment for severe alopecia areata with Lilly's Olumiant
14 January 2026 - Eli Lilly Canada announced today that Ontario leads the way as the first province to add Olumiant ...
Posted by Michael Wonder on 14 Jan 2026
TGA approves registration of lenacapavir for pre-exposure prophylaxis for HIV (Yeytuo)
9 January 2026 - On 17 December 2025, the TGA made the decision to approve the registration of lenacapavir (Yeytuo). ...
Posted by Michael Wonder on 14 Jan 2026
Sandoz confirms European Commission approval of Ondibta (insulin glargine), strengthening overall biosimilars leadership and position in diabetes
14 January 2026 - Expected launch by early 2027; potential to expand access to insulin treatment option for tens of millions ...
Posted by Michael Wonder on 14 Jan 2026
Travere Therapeutics announces FDA extends review of sNDA for Filspari (sparsentan) in FSGS
13 January 2026 - Travere Therapeutics announced that today the US FDA has extended the review timeline of its supplemental new ...
Posted by Michael Wonder on 14 Jan 2026
Henlius' fifth US filing product bevacizumab biosimilar HLX04 receives FDA BLA acceptance
13 January 2026 - Shanghai Henlius Biotech announced that the biologics license application for HLX04, the Company’s independently developed bevacizumab biosimilar ...
Posted by Michael Wonder on 14 Jan 2026
FDA confirms a PDUFA goal date of 30 August 2026 for the sBLA submission of ropeginterferon alfa-2b-njft in essential thrombocythemia
13 January 2026 - PharmaEssentia today announced that the US FDA has accepted the Company’s supplemental biologics license application for ropeginterferon ...