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RSS FeedPosted by Michael Wonder on 15 Jul 2025
US FDA approves finerenone for new indication in patients with heart failure with left ventricular ejection fraction of ≥40%
14 July 2025 - New indication approval follows the US FDA’s priority review designation and is based on positive results from ...
Posted by Michael Wonder on 15 Jul 2025
FDA grants Zenith’s ZEN-3694 fast track status
14 July 2025 - Zenith Epigenetics is pleased to announce the designation of ZEN-3694 as a fast track product by the ...
Posted by Michael Wonder on 15 Jul 2025
Moderna receives full US FDA approval for COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years at increased risk for COVID-19 disease
10 July 2025 - Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 ...
Posted by Michael Wonder on 13 Jul 2025
Milestone Pharmaceuticals announces FDA acceptance of the company’s response to the CRL for Cardamyst (etripamil) nasal spray
11 July 2025 - New PDUFA action date of 13 December 2025. ...
Posted by Michael Wonder on 13 Jul 2025
Ultragenyx receives complete response letter from FDA for UX111 AAV gene therapy to treat Sanfilippo syndrome type A
11 July 2025 - complete response letter cited specific chemistry, manufacturing and controls related observations that are resolvable. ...
Posted by Michael Wonder on 11 Jul 2025
Transcend Therapeutics receives breakthrough therapy designation for TSND- 201 (methylone) for the treatment of PTSD
10 July 2025 - Company planning to initiate Phase 3 program. ...
Posted by Michael Wonder on 11 Jul 2025
FDA grants fast track designation for TRE-515 in combination with radiation therapy for the treatment of metastatic castration resistant prostate cancer
9 July 2025 - Trethera announced today that the US FDA has granted fast track designation for its novel drug, TRE-515, ...
Posted by Michael Wonder on 11 Jul 2025
Capricor Therapeutics provides regulatory update on deramiocel BLA for Duchenne muscular systrophy
11 July 2025 - Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in ...
Posted by Michael Wonder on 09 Jul 2025
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease
9 July 2025 - The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding ...
Posted by Michael Wonder on 09 Jul 2025
Supplemental new drug application submitted to US FDA for Caplyta (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
8 July 2025 - Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in ...
Posted by Michael Wonder on 08 Jul 2025
Lexeo Therapeutics announces FDA breakthrough therapy designation for LX2006 in Friedreich ataxia
7 July 2025 - Breakthrough therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in ...
Posted by Michael Wonder on 08 Jul 2025
Denali Therapeutics announces FDA acceptance and priority review of biologics license application for tividenofusp alfa for Hunter syndrome
7 July 2025 - FDA assigns PDUFA target action date of 5 January 2026, for decision on accelerated approval. ...
Posted by Michael Wonder on 07 Jul 2025
KalVista Pharmaceuticals announces FDA Approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema
7 July 2025 - First new on demand hereditary angioedema treatment in over a decade, with potential to transform management of the ...
Posted by Michael Wonder on 05 Jul 2025
Vitalgen's gene therapy drug VGN-R09b for primary Parkinson's disease receives FDA fast track designation
26 June 2025 - Shanghai Vitalgen announced that its gene therapy drug, VGN-R09b, for the treatment of primary Parkinson’s disease, has ...
Posted by Michael Wonder on 03 Jul 2025
FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
2 July 2025 - Today, the FDA granted accelerated approval to sunvozertinib (Zegfrovy, Dizal) for adult patients with locally advanced ...