Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 15 Jul 2025
Sun Pharma announces launch of Leqselvi (deuruxolitinib) in the US for the treatment of severe alopecia areata
14 July 2025 - Leqselvi now available for prescription in US nationwide, offering a new option for eligible patients ...
Posted by Michael Wonder on 15 Jul 2025
Vertex announces broad reimbursement agreement with NHS England for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) an innovative once daily CFTR modulator for the treatment of cystic fibrosis
14 July 2025 - All eligible people with cystic fibrosis in England can now benefit from this medicine - ...
Posted by Michael Wonder on 15 Jul 2025
Health Canada extends the approval of Evkeeza (evinacumab) to children as young as 6 months old with homozygous familial hypercholesterolaemia
14 July 2025 - Ultragenyx today announced that Health Canada has extended the approval of Evkeeza (evinacumab) as an adjunct to ...
Posted by Michael Wonder on 15 Jul 2025
Atara Biotherapeutics provides regulatory and business updates on tabelecleucel
14 July 2025 - Atara Biotherapeutics resubmits tabelecleucel biologics license application for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease to ...
Posted 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 14 Jul 2025
Astellas Korea renews bid to reimburse targeted gastric cancer drug Vyloy
11 July 2025 - Astellas Korea will reapply for health insurance coverage for its new drug Vyloy (zolbetuximab), a targeted ...
Posted by Michael Wonder on 13 Jul 2025
Delgocitinib for the treatment of patients with moderate to severe chronic hand eczema
8 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 13 Jul 2025
Zanubrutinib for the treatment of patients with relapsed or refractory mantle cell lymphoma
10 July 2025 - NICE has published final evidence-based recommendations on the use of zanubrutinib for the treatment of adults ...
Posted by Michael Wonder on 13 Jul 2025
Bayer files for EU approval of gadoquatrane
10 July 2025 - Submission of marketing authorization application to the EMA seeking approval for investigational low dose gadoquatrane for contrast-enhanced ...
Posted by Michael Wonder on 13 Jul 2025
European Commission approves Tevimbra in combination with chemotherapy as a first-line treatment for nasopharyngeal carcinoma
10 July 2025 - New indication based on results of RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival. ...
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. ...