Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 27 Jun 2022
FDA introduces innovative proposal to advance consumer access to non-prescription drugs
27 June 2022 - Proposed rule is intended to increase options for the development of safe and effective non-prescription drugs. ...
Posted by Michael Wonder on 27 Jun 2022
Positive MHRA decision for Briviact
24 June 2022 - MHRA extends UCB’s therapy for the treatment of partial-onset seizures. ...
Posted by Michael Wonder on 27 Jun 2022
European Commission approves Keytruda (pembrolizumab) as adjuvant treatment for adult and adolescent patients (≥12 years of age) with stage IIB or IIC melanoma following complete resection
24 June 2022 - Approval based on recurrence-free survival and distant metastasis-free survival benefit demonstrated by KEYTRUDA in the Phase 3 ...
Posted by Michael Wonder on 27 Jun 2022
FYB201, Formycon's biosimilar for Lucentis (ranibizumab), receives CHMP recommendation from EMA
24 June 2022 - Formycon and its licensing partner Bioeq announce that the CHMP of the EMA today issued a ...
Posted by Michael Wonder on 27 Jun 2022
Trastuzumab deruxtecan supplemental new drug application submitted in Japan for patients with HER2 low metastatic breast cancer
27 June 2022 - Submission based on DESTINY-Breast04 results that showed trastuzumab deruxtecan demonstrated superior progression-free survival and overall survival ...
Posted by Michael Wonder on 27 Jun 2022
Lynparza recommended for approval in the EU by CHMP as adjuvant treatment for patients with germline BRCA mutated HER2 negative high risk early breast cancer
27 June 2022 - First PARP inhibitor to improve overall survival in early-stage breast cancer. ...
Posted by Michael Wonder on 27 Jun 2022
CHMP recommends approval of upadacitinib (Rinvoq) for the treatment of adults with active non-radiographic axial spondyloarthritis
27 June 2022 - CHMP positive opinion is based on results from the Phase 3 SELECT-AXIS 2 study showing upadacitinib (RINVOQ®) ...
Posted by Michael Wonder on 27 Jun 2022
Trastuzumab deruxtecan recommended for approval in the EU by CHMP for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
27 June 2022 - Recommendation based on DESTINY-Breast03 trial results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced the risk ...
Posted by Michael Wonder on 27 Jun 2022
Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma (CT-P16)
27 June 2022 - The positive opinion is based on the totality of evidence including the Phase III study to evaluate ...
Posted by Michael Wonder on 26 Jun 2022
US seeks pharmaceutical deal with Switzerland to fast-track FDA approvals
27 June 2022 - The Biden administration wants to reach a narrow sectoral trade agreement with the Swiss pharmaceutical industry, ...
Posted by Michael Wonder on 26 Jun 2022
Price disclosure 2022 October cycle outcomes summary
24 June 2022 - The summary of price disclosure price reductions for the 2022 October Cycle has now been published on ...
Posted by Michael Wonder on 26 Jun 2022
PHARMAC widens flu vaccine access to increase uptake
27 June 2022 - PHARMAC today announced that it is permanently widening access to the annual funded flu vaccine to people ...
Posted by Michael Wonder on 26 Jun 2022
CHMP issues a positive opinion recommending full approval of Oncopeptides Pepaxti in EU for patients with triple class refractory multiple myeloma
23 June 2022 - Oncopeptides today announces that the EMA's CHMP, has unanimously adopted a positive opinion recommending a full marketing ...
Posted by Michael Wonder on 26 Jun 2022
Amryt to pursue formal dispute resolution for Oleogel-S10 (Filsuvez) NDA
24 June 2022 - Amryt today announces that the company plans to submit a formal dispute resolution request for the ...
Posted by Michael Wonder on 26 Jun 2022
Emergent BioSolutions announces FDA acceptance of biologics license application for AV7909 anthrax vaccine candidate
24 June 2022 - Emergent BioSolutions announced today that the U.S. FDA accepted for review the biologics license application for AV7909 ...