Blog
RSS FeedPosted by Michael Wonder on 18 Jun 2025
Cancer inhibitors scrapped from basic insurance for some users
18 June 2025 - National health care institute Zorginstituut Nederland has scrapped several cancer inhibiting drugs from the basic health ...
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. ...
Posted by Michael Wonder on 11 Jul 2025
Zepbound KwikPen (tirzepatide), the first and only dual receptor agonist for the treatment of obesity, now approved and available in Canada
9 July 2025 - Eli Lilly Canada is pleased to announce that Zepbound KwikPen (tirzepatide injection) is now available in Canada, ...
Posted by Michael Wonder on 11 Jul 2025
Swissmedic approves Ifinwil (eflornithine) for children diagnosed with high-risk neuroblastoma
8 July 2025 - Norgine is pleased to announce that Swissmedic has approved the registration of Ifinwil (eflornithine) as monotherapy ...
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 10 Jul 2025
MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
8 July 2025 - The MHRA has today become the first regulator in the world to approve elinzanetant (Lynkuet) for the ...
Posted by Michael Wonder on 10 Jul 2025
Albanese should consider tweaks to PBS to avoid Trump tariff: CSL chair
9 July 2025 - Donald Trump’s move to ramp up tariffs on medicines and copper has sparked alarm among government ...
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
New Wegovy dose submitted to EMA for approval, with 1 in 3 trial participants achieving 25% or more weight loss
8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...