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 03 Jun 2024
Tris Pharma receives US FDA approval for once daily Onyda XR (clonidine hydrochloride) extended release oral suspension, the first and only liquid non-stimulant ADHD medication
29 May 2024 - First non-stimulant ADHD medication, with nighttime dosing, adds to Tris Pharma’s established portfolio of leading ADHD therapies ...
Posted by Michael Wonder on 03 Jun 2024
Project Orbis: quicker access to promising cancer treatments
29 May 2024 - Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs. ...
Posted by Michael Wonder on 03 Jun 2024
Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo for the treatment of IgA nephropathy
30 May 2024 - Calliditas Therapeutics today announced that the CHMP of the EMA adopted a positive opinion recommending the ...
Posted by Michael Wonder on 03 Jun 2024
Teva announces Austedo XR (deutetrabenazine) extended release tablets now US FDA approved as a one pill, once daily treatment option for clinically therapeutic doses (24 mg–48 mg/day)
29 May 2024 - US FDA approves new one pill, once daily Austedo XR tablets (30 mg, 36 mg, 42 ...
Posted by Michael Wonder on 03 Jun 2024
Zanidatamab granted priority review for HER2 positive metastatic biliary tract cancer
29 May 2024 - Target action (PDUFA) date set for 29 November 2024. ...
Posted by Michael Wonder on 03 Jun 2024
Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency
31 May 2024 - Zealand Pharma today announced that the CHMP of the EMA has issued a positive opinion recommending granting ...
Posted by Michael Wonder on 02 Jun 2024
Mirum Pharmaceuticals announces positive CHMP opinion for Livmarli (maralixibat) oral solution for the treatment of PFIC in patients three months of age and older
31 May 2024 - Positive opinion from CHMP based on Phase 3 MARCH study with highly statistically significant (p<0.0001) reduction in ...
Posted by Michael Wonder on 02 Jun 2024
US FDA acknowledges Astellas' resubmission of biologics license application for zolbetuximab and sets new action date
30 May 2024 - If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and ...
Posted by Michael Wonder on 02 Jun 2024
Takeda receives positive CHMP opinion for recombinant ADAMTS13 (rADAMTS13) in congenital thrombotic thrombocytopenic purpura
31 May 2024 - Positive opinion based on totality of evidence, including results from the first randomised, controlled, cpen-label, cross-over Phase ...
Posted by Michael Wonder on 02 Jun 2024
Dupixent recommended for EU approval by the CHMP to treat patients with COPD
31 May 2024 - Recommendation for adults with uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils based on data from ...
Posted by Michael Wonder on 02 Jun 2024
AbbVie receives positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderately to severely active ulcerative colitis
31 May 2024 - The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that ...
Posted by Michael Wonder on 01 Jun 2024
New analysis examines role of conditional approvals on access to promising oncology therapies
31 May 2024 - Health Canada’s Notice of Compliance with conditions (NOC/c) policy has been effective in providing people in Canada ...
Posted by Michael Wonder on 01 Jun 2024
Cancer is capsizing Americans’ finances. ‘I was losing everything.’
28 May 2024 - Higher drug prices, rising out of pocket costs and reduced incomes create economic strain for many patients. ...
Posted by Michael Wonder on 01 Jun 2024
New gene therapy treatment for haemophilia B
31 May 2024 - The EMA has recommended granting a conditional marketing authorisation in the European Union for Durveqtix (fidanacogene ...
Posted by Michael Wonder on 01 Jun 2024
First vaccine to protect adults from Chikungunya
31 May 2024 - EMA has recommended granting a marketing authorisation in the European Union for Ixchiq, the first vaccine ...