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RSS FeedPosted 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 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
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; ...
Posted by Michael Wonder on 28 Jun 2026
Viridian Therapeutics announces US FDA approval and launch of Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease
26 June 2026 - First approved treatment for thyroid eye disease with labeling that includes data for both active and chronic ...
Posted by Michael Wonder on 26 Jun 2026
Tryngolza (olezarsen) approved by the FDA as the first and only treatment to reduce triglycerides and the risk of acute pancreatitis in patients with severe hypertriglyceridemia
24 June 2026 - Ionis Pharmaceuticals today announced that the US FDA has approved Tryngolza (olezarsen) as an adjunct to ...
Posted by Michael Wonder on 26 Jun 2026
FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer
24 June 2026 - Today, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences) for two indications in adults with triple ...
Posted by Michael Wonder on 26 Jun 2026
Celecor completes submission of FDA new drug application for investigational heart attack drig
24 June 2026 - CeleCor Therapeutics has submitted the final section of its new drug application for the company's investigational ...