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RSS FeedPosted 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
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
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, ...
Posted by Michael Wonder on 01 Apr 2026
Oculis announces EMA PRIME designation for privosegtor, advancing a potential first in class neuroprotective candidate for optic neuritis
31 March 2026 - Decision supported by positive Phase 2 ACUITY data showing substantial improvements in vision combined with anatomical and ...
Posted by Michael Wonder on 01 Apr 2026
Vertex announces US FDA approval for label extensions of Alyftrek and Trikafta, expanding availability of these medicines to ~95% of all people with CF in the United States
1 April 2026 - Vertex Pharmaceuticals today announced the US FDA has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the ...
Posted by Michael Wonder on 01 Apr 2026
Orca Bio announces FDA review extension of BLA for Orca-T for the treatment of haematologic malignancies
1 April 2026 - Orca Bio today announced that the US FDA has extended the review timeline of its biologics license ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves first new molecular entity under National Priority Voucher Program
1 April 2026 - The US FDA today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher ...
Posted by Michael Wonder on 01 Apr 2026
Scholar Rock resubmits biologics license application to FDA for apitegromab for treatment of children and adults with spinal muscular atrophy
31 March 2026 - Apitegromab biologics license application resubmission includes Catalent Indiana (part of Novo Nordisk) and second US based fill ...
Posted by Michael Wonder on 01 Apr 2026
Henlius receives two positive CHMP opinions for serplulimab, advancing global regulatory progress
30 March 2026 - Shanghai Henlius Biotech today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly), ...
Posted by Michael Wonder on 31 Mar 2026
European Commission approves Kygevi (doxecitine and doxribtimine) as first and only treatment for thymidine kinase 2 deficiency
31 March 2026 – UCB today announced that the European Commission has granted marketing authorisation under exceptional circumstances for Kygevi ...