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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 03 Apr 2026
Sevabertinib approved to treat adults with HER2 positive lung cancer that has spread or cannot be removed by surgery
2 April 2026 - The MHRA has approved sevabertinib (Hyrnuo) to treat adults with advanced non-small cell lung cancer with ...
Posted by Michael Wonder on 03 Apr 2026
NHS patients and British businesses to benefit from historic changes to medicines access following pharmaceutical partnership with US
2 April 2026 - New partnership accelerates NHS patients' access to new medicines and will see UK benefit from greater life ...
Posted by Michael Wonder on 03 Apr 2026
Trump slaps 100pc tariffs on Australian drugs – with exceptions
3 April 2026 - Australian drug makers that do not build new factories in America and dramatically cut their prices ...
Posted by Michael Wonder on 03 Apr 2026
Changes to NICE’s cost effectiveness thresholds take effect
2 April 2026 - NICE has implemented new measures to evaluate the cost effectiveness of medicines, following a policy change that ...
Posted by Michael Wonder on 03 Apr 2026
MHRA-NICE pathway opens for business – everything you need to know to get started
1 April 2026 - Today marks a significant milestone for patients, the NHS and the pharmaceutical industry. From 1 April 2026, ...
Posted by Michael Wonder on 03 Apr 2026
Context Therapeutics announces CTIM-76 receives FDA fast track designation for the treatment of platinum-resistant ovarian cancer
2 April 2026 - Context Therapeutics today announced that the US FDA has granted fast track designation to CTIM-76, a ...
Posted by Michael Wonder on 02 Apr 2026
Cocrystal Pharma receives FDA fast track designation for CDI-988 for norovirus infection treatment and preventive
2 April 2026 - Cocrystal Pharma announces that the US FDA has granted fast track designation to its oral, direct-acting ...
Posted by Michael Wonder on 02 Apr 2026
Ultragenyx announces US FDA acceptance of BLA resubmission for UX111 AAV gene therapy to treat Sanfilippo syndrome type A
2 April 2026 - Ultragenyx Pharmaceutical today announced the US FDA has accepted for review the resubmitted biologics license application seeking ...
Posted by Michael Wonder on 02 Apr 2026
Eylea HD (aflibercept) approved by FDA as first and only injectable anti-VEGF with dosing intervals up to 5 months for wet age-related macular degeneration and diabetic macular oedema
2 April 2026 - Regeneron Pharmaceuticals today announced that the US FDA has approved the extension of dosing intervals for EYlea ...
Posted by Michael Wonder on 02 Apr 2026
AbbVie's Epkinly gets health insurance coverage for DLBCL in Korea
1 April 2026 - AbbVie Korea said Wednesday that its bispecific antibody Epkinly (epcoritamab), will receive national health insurance coverage ...
Posted by Michael Wonder on 02 Apr 2026
Fore Biotherapeutics receives breakthrough therapy designation for plixorafenib
1 April 2026 - Fore Biotherapeutics today announced that the US FDA has granted breakthrough therapy designation to plixorafenib for the ...
Posted by Michael Wonder on 02 Apr 2026
Trump puts Australia’s drugs scheme, digital rules in firing line
1 April 2026 - Donald Trump’s top trade tsar claims Australia’s unfair drug pricing practices are undermining US innovation, warns ...
Posted by Michael Wonder on 02 Apr 2026
Pasithea Therapeutics announces grant of fast track designation by FDA to PAS-004 for treatment of neurofibromatosis type 1 associated plexiform neurofibromas causing significant morbidity
1 April 2026 - Pasithea Therapeutics today announced that the US FDA has granted fast track designation to PAS-004 for ...
Posted by Michael Wonder on 02 Apr 2026
A2 Biotherapeutics receives US FDA fast track designation for A2B543, a logic-gated CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster
1 April 2026 - A2 Biotherapeutics today announced that the US FDA has granted fast track designation for A2B543, an autologous ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions
1 April 2026 - Foundayo, Lilly's second FDA approved obesity medicine, will be available via LillyDirect with free home delivery, ...