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RSS FeedPosted by Michael Wonder on 03 Jul 2026
Selective PPARα modulator “K-808” (pemafibrate) granted breakthrough therapy designation by the US FDA as a treatment for primary biliary cholangitis
30 June 2026 - Kowa today announced that on 11 June 2026, it received breakthrough therapy designation from the US FDA ...
Posted by Michael Wonder on 03 Jul 2026
FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies
30 June 2026 - Today, the FDA approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell and ...
Posted by Michael Wonder on 02 Jul 2026
Cogent Biosciences announces submission of new drug application for bezuclastinib in advanced systemic mastocytosis
30 June 2026 - Cogent Biosciences today announced it has submitted its new drug application to the US FDA for ...
Posted by Michael Wonder on 02 Jul 2026
Galderma provides progress update regarding relabotulinumtoxinA regulatory submission in the US
1 July 2026 - Galderma today provided progress updates regarding the regulatory review of its pending biologics license application for relabotulinumtoxinA ...
Posted by Michael Wonder on 02 Jul 2026
Unicycive Therapeutics receives complete response letter from FDA regarding resubmitted oxylanthanum carbonate new drug application
30 June 2026 - Unicycive Therapeutics today announced that it has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 02 Jul 2026
FDA grants priority review to Roche’s Enspryng, the first and only at home subcutaneous treatment option for thyroid eye disease
30 June 2026 - Roche announced today that the US FDA has accepted and granted priority review to a supplemental biologics ...
Posted by Michael Wonder on 02 Jul 2026
INTENT Biologics receives FDA breakthrough therapy designation for PEP Biologic for its Phase 3 ready flagship indication
1 July 2026 - INTENT Biologics announced today that the US FDA has granted breakthrough therapy designation for PEP Biologic ...
Posted by Michael Wonder on 02 Jul 2026
FDA approves first gene therapy for young children with sickle cell disease
1 July 2026 - The US FDA today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years ...
Posted by Michael Wonder on 30 Jun 2026
Satellos receives FDA fast track designation for SAT-3247 for the treatment of Duchenne muscular dystrophy
29 June 2026 - SAT-3247 has now received FDA fast track, orphan drug and rare paediatric disease designations for Duchenne muscular ...
Posted by Michael Wonder on 30 Jun 2026
Praxis Precision Medicines announces extension period for relutrigine for treatment of SCN2A and SCN8A developmental and epileptic encephalopathies
29 June 2026 - FDA sets updated PDUFA date of 27 December 2026 ...
Posted by Michael Wonder on 30 Jun 2026
FDA approves Arcutis’ Zorvye (roflumilast) cream 0.3% for the treatment of plaque psoriasis in children as young as age 2
29 June 2026 - Arcutis Biotherapeutics today announced that the US FDA has approved the supplemental new drug application to ...
Posted by Michael Wonder on 28 Jun 2026
Skyrizi (risankizumab-rzaa) now FDA approved for paediatric use in psoriatic disease
26 June 2026 - AbbVie today announced the US FDA has approved Skyrizi (risankizumab-rzaa) for the treatment of children six years ...
Posted by Michael Wonder on 28 Jun 2026
Replimune announces FDA acceptance of RP1 biologics license application resubmission for advanced melanoma
26 June 2026 - FDA decision expected by 2 August 2026. ...
Posted by Michael Wonder on 28 Jun 2026
Lantheus receives complete response letter from FDA for LNTH-2501 (Ga 68 edotreotide)
26 June 2026 - Lantheus Holdings announced today that the US FDA has issued a complete response letter regarding its ...
Posted by Michael Wonder on 28 Jun 2026
Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)
26 June 2026 - The FDA has requested additional data related to chemistry, manufacturing, and controls and contract manufacturing facilities; ...