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RSS FeedPosted by Michael Wonder on 07 Oct 2025
Enhertu plus pertuzumab supplemental new drug application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer
7 October 2025 - Submission based on DESTINY-Breast09 Phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk ...
Posted by Michael Wonder on 07 Oct 2025
Jesse's dad, who walked Canada for his son, cheers approval of new Duchenne drug
3 October 2025 - Vamorolone is the first Health Canada approved drug developed specifically to treat Duchenne. ...
Posted by Michael Wonder on 07 Oct 2025
Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)
6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...
Posted by Michael Wonder on 07 Oct 2025
European marketing application for AVT23, a proposed biosimilar to Xolair (omalizumab), accepted by the EMA
6 October 2025 - Advanz Pharma today announced that the EMA has accepted a marketing authorisation application for AVT23, a proposed ...
Posted by Michael Wonder on 07 Oct 2025
FDA approves Arcutis’ Zoryve (roflumilast) cream 0.05% for the treatment of atopic dermatitis in children ages 2 to 5
6 October 2025 - Commercial product expected to be available by the end of October 2025. ...
Posted by Michael Wonder on 07 Oct 2025
Spruce Biosciences receives US FDA breakthrough therapy designation for tralesinidase alfa enzyme replacement therapy in Sanfilippo syndrome type B
6 October 2025 - Breakthrough therapy designation supported by integrated long-term clinical data demonstrating normalisation in cerebral spinal fluid heparan sulphate ...
Posted by Michael Wonder on 06 Oct 2025
Amgen makes Repatha available though AmgenNow, a direct to patient program in the US
6 October 2025 - Eligible patients can access Repatha at nearly 60% discount from the list price. ...
Posted by Michael Wonder on 05 Oct 2025
Why Pfizer’s Trump deal is good news for all of big pharma
2 October 2025 - The company’s accord with the president clears a cloud over the whole sector. ...
Posted by Michael Wonder on 04 Oct 2025
Andexanet alfa for haemorrhage: hope not fulfilled
1 October 2025 - A comparative study conducted at the instigation of the EMA shows only negative effects. ...
Posted by Michael Wonder on 04 Oct 2025
Ensem Therapeutics announces ETX-636 granted fast track designation by the FDA for advanced breast cancer
1 October 2025 - Ensem Therapeutics today announced the US FDA granted fast track designation to its clinical stage pan mutant-specific ...
Posted by Michael Wonder on 04 Oct 2025
Does big pharma gouge Americans?
2 October 2025 - In the bloated health care system, others are the real money makers. ...
Posted by Michael Wonder on 04 Oct 2025
FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer
3 October 2025 - Regimen recommended in National Comprehensive Cancer Network Guidelines for small cell lung cancer. ...
Posted by Michael Wonder on 03 Oct 2025
Alto Neuroscience receives FDA fast track designation for ALTO-101 for the treatment of cognitive impairment associated with schizophrenia
3 October 2025 - Alto Neuroscience today announced that the US FDA has granted fast track designation to ALTO-101 for the ...
Posted by Michael Wonder on 03 Oct 2025
Bristol Myers Squibb plans to launch Cobenfy (xanomeline and trospium chloride) in the UK at a list price equal to the US launch price
22 September 2025 - Bristol Myers Squibb plans to launch Cobenfy (xanomeline and trospium chloride), in the UK in 2026. ...
Posted by Michael Wonder on 03 Oct 2025
Health Canada approves Agamree (vamorolone) as the first treatment for Duchenne muscular dystrophy in Canada
2 October 2025 - Kye Pharmaceuticals announced today that Health Canada has approved Agamree (vamorolone) for the treatment of Duchenne muscular ...