Blog
RSS FeedPosted by Michael Wonder on 01 Jul 2025
Unicycive Therapeutics announces receipt of complete response letter for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
30 June 2025 - No other concerns stated, including pre-clinical, clinical, or safety data. ...
Posted by Michael Wonder on 28 Jun 2025
FDA approves Gamifant (emapalumab-lzsg) as first-ever treatment for adults and children with Macrophage Activation Syndrome in Still's disease
28 June 2025 - Approval based on the pooled analysis of our pivotal EMERALD and NI-0501-06 studies, showing 54% of ...
Posted by Michael Wonder on 27 Jun 2025
Achieve Life Sciences announces submission of NDA to FDA for cytisinicline as a treatment of nicotine dependence for smoking cessation
26 June 2025 - More than 2,000 clinical trial participants contributed to the body of evidence submitted in the new drug ...
Posted 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 22 Jun 2025
Update on FDA review of ruxolitinib cream (Opzelura) for children ages 2-11 with atopic dermatitis
20 June 2025 - Incyte today announced that the US FDA has extended the review period for the supplemental new ...
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 19 Jun 2025
Bayer files for approval of gadoquatrane in the US
17 June 2025 - Bayer today announced the submission of a new drug application to the US FDA for its ...
Posted by Michael Wonder on 18 Jun 2025
Aldeyra Therapeutics resubmits reproxalap new drug application for the treatment of dry eye disease
17 June 2025 - Aldeyra Therapeutics today announced the resubmission of a new drug application to the US FDA for ...
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 18 Jun 2025
Yeztugo (lenacapavir) is now the first and only FDA approved HIV prevention option offering 6 months of protection
18 June 2025 - Approval based on Phase 3 PURPOSE 1 and PURPOSE 2 data that showed ≥99.9% of participants remained ...
Posted by Michael Wonder on 18 Jun 2025
Johnson & Johnson seeks US FDA approval of Stelara (ustekinumab) for the treatment of paediatric Crohn’s disease
17 June 2025 - Supported by 52 week data from the Phase 3 UNITI-Jr study, submission aims to expand Stelara indication ...
Posted by Michael Wonder on 17 Jun 2025
Milestone Pharmaceuticals submits response to the FDA’s CRL for Cardamyst (etripamil) nasal spray for PSVT following type A meeting
16 June 2025 - Milestone Pharmaceuticals today announced submission of its response to the US FDA’s complete response letter regarding its ...