Blog
RSS FeedPosted by Michael Wonder on 26 Jun 2025
FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support diagnosis of Alzheimer’s disease in patients
25 June 2025 - Eli Lilly announced that the US FDA has approved a label update for Amyvid (florbetapir F ...
Posted by Michael Wonder on 25 Jun 2025
FDA approves Benlysta (belimumab) auto-injector for children with active lupus nephritis
24 June 2025 - With this approval, paediatric patients aged five years and older with active lupus nephritis will have ...
Posted by Michael Wonder on 23 Jun 2025
FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
23 June 2025 - Today, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo) for adults with locally ...
Posted by Michael Wonder on 20 Jun 2025
Cycle Pharmaceuticals’ Harliku (nitisinone) tablets receive first FDA approval as treatment for alkaptonuria
19 June 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic ...
Posted by Michael Wonder on 20 Jun 2025
Dupixent (dupilumab) approved in the US as the only targeted medicine to treat patients with bullous pemphigoid
20 June 2025 - Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral ...
Posted by Michael Wonder on 18 Jun 2025
FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
18 June 2025 - Today, the FDA approved tafasitamab-cxix (Monjuvi, Incyte) with lenalidomide and rituximab for adults with relapsed or ...
Posted by Michael Wonder on 17 Jun 2025
US FDA approves CSL's Andembry (garadacimab-gxii), the only prophylactic hereditary angioedema treatment targeting factor XIIa with once monthly dosing for all patients from the start
16 June 2025 - Once monthly dosing reduced HAE attacks by a median of more than 99% and a least squares ...
Posted by Michael Wonder on 16 Jun 2025
Celltrion announces US FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients
15 June 2025 - Approval of 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for ...
Posted by Michael Wonder on 14 Jun 2025
Moderna receives US FDA approval for RSV vaccine, mRESVIA, in adults aged 18–59 at increased risk for RSV disease
12 June 2025 - Expanded indication builds on existing US FDA approval of mRESVIA for adults aged 60 and older. ...
Posted by Michael Wonder on 12 Jun 2025
FDA approves neo-adjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
12 June 2025 - Today, the FDA approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head and neck ...
Posted by Michael Wonder on 12 Jun 2025
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
12 June 2025 - Today, the FDA approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade ...
Posted by Michael Wonder on 12 Jun 2025
US FDA approves tablet formulation of BeOne’s Brukinsa for all approved indications
11 June 2025 - New formulation provides patients with a simplified dosing experience—reducing pill burden and enhancing ease of administration—while ...
Posted by Michael Wonder on 11 Jun 2025
FDA approves taletrectinib for ROS1 positive non-small cell lung cancer
11 June 2025 - Today, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced ...
Posted by Michael Wonder on 11 Jun 2025
US FDA approves expanded indication for AbbVie's Mavyret (glecaprevir/pibrentasvir) as first and only treatment for people with acute hepatitis C virus
11 June 2025 - AbbVie today announced that the US FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral ...
Posted by Michael Wonder on 11 Jun 2025
Azurity Pharmaceuticals announces the FDA approval of Xifyrm (meloxicam injection) for the management of moderate to severe pain in adults
10 June 2025 - Azurity Pharmaceuticals today announced that the US FDA has approved Xifyrm (meloxicam injection), an intravenous non-steroidal ...