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RSS FeedPosted by Michael Wonder on 29 Aug 2025
Agenda for the September 2025 PBAC intracycle meeting
29 August 2025 - The agenda for the September 2025 PBAC intracycle meeting is now available. ...
Posted by Michael Wonder on 29 Aug 2025
Tolremo Therapeutics receives two FDA fast track designations for TT125-802 in pretreated, advanced or metastatic NSCLC with either an EGFR or a KRAS G12C mutation
28 August 2025 - – Tolremo Therapeutics today announced that their lead candidate, TT125-802, received two fast track designations from the ...
Posted by Michael Wonder on 28 Aug 2025
D3 Bio announces FDA breakthrough therapy designation and orphan drug designation for D3S-001 for the treatment of patients with KRAS G12C mutated cancers
28 August 2025 - D3 Bio today announced that the US FDA has granted a breakthrough therapy designation to D3S-001, the ...
Posted by Michael Wonder on 28 Aug 2025
European Commission approves Tevimbra as neo-adjuvant/adjuvant NSCLC treatment
27 August 2025 - Final analysis of RATIONALE-315 demonstrates clear overall survival benefit in peri-operative setting in resectable non-small cell lung ...
Posted by Michael Wonder on 28 Aug 2025
MHRA approves UK’s first new type of antibiotic for urinary tract infections in nearly 30 years
28 August 2025 - The MHRA has approved gepotidacin (Blujepa), a new kind of oral antibiotic pill to treat uncomplicated urinary ...
Posted by Michael Wonder on 28 Aug 2025
MHRA approves zuranolone to treat postnatal depression in adults following childbirth
27 August 2025 - The MHRA has approved zuranolone (Zurzuvae) to treat moderate or severe postnatal depression in adults following childbirth. ...
Posted by Michael Wonder on 28 Aug 2025
Outlook Therapeutics provides regulatory update on US FDA review of ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of wet AMD
28 August 2025 - Outlook Therapeutics plans to work with FDA to address the Agency’s issues. ...
Posted by Michael Wonder on 28 Aug 2025
Rinvoq (upadacitinib) receives Health Canada notice of compliance for giant cell arteritis in adults
27 August 2025 - This marks the eighth approved indication for Rinvoq in Canada across rheumatology, gastro-enterology and dermatology. ...
Posted by Michael Wonder on 27 Aug 2025
Leo Pharma announces Health Canada approval of Anzupgo for treatment of moderate to severe chronic hand eczema
26 August 2025 - Approval was based on results from the DELTA 1 and 2 trials, which evaluated the safety and ...
Posted by Michael Wonder on 27 Aug 2025
Cereno Scientific granted FDA fast track designation for CS1 in rare disease pulmonary arterial hypertension
26 August 2025 - Cereno Scientific today announced that the US FDA has granted fast track designation to its lead program, ...
Posted by Michael Wonder on 27 Aug 2025
Genmab receives FDA breakthrough therapy designation for rinatabart sesutecan in advanced endometrial cancer
t26 August 2025 - Genmab announced today that the US FDA has granted breakthrough therapy designation to rinatabart sesutecan, an investigational ...
Posted by Michael Wonder on 26 Aug 2025
Allarity Therapeutics granted FDA fast track designation for stenoparib for the treatment of advanced ovarian cancer
26 August 2025 - Allarity Therapeutics today announced that the US FDA has granted fast track designation to stenoparib, its investigational ...
Posted by Michael Wonder on 26 Aug 2025
Repatha now indicated for adults at increased risk for major adverse cardiovascular events due to uncontrolled LDL-C
25 August 2025 - Amgen today announced that the US FDA has broadened the approved use of Repatha (evolocumab) to include ...
Posted by Michael Wonder on 26 Aug 2025
European Commission authorises twice yearly Yeytuo (lenacapavir) for HIV prevention
26 August 2025 - Accelerated EC decision comes after US FDA approval in June. ...
Posted by Michael Wonder on 26 Aug 2025
Ayrmid announces FDA acceptance and priority review for omidubicel for the treatment of severe aplastic anaemia
25 August 2025 - Ayrmid today announced that the US FDA has accepted the Company’s priority review application for omidubicel for ...