Blog
RSS FeedPosted by Michael Wonder on 26 Jun 2025
BeOne Medicines receives positive CHMP opinion for tablet formulation of Brukinsa
25 June 2025 - BeOne Medicines today announced that the CHMP of the EMA issued a positive opinion recommending approval ...
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 24 Jun 2025
EMA recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept)
23 June 2025 - Alvotech and Advanz Pharma today announced that the EMA's CHMP adopted a positive opinion recommending approval for ...
Posted by Michael Wonder on 24 Jun 2025
Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma
23 June 2025 - Recommendation based on GMMG-HD7 Phase 3 study demonstrating that Sarclisa with bortezomib, lenalidomide, and dexamethasone induction treatment significantly ...
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 23 Jun 2025
MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer
20 June 2025 - The MHRA has today approved serplulimab (Hetronifly) to treat adults with extensive-stage small cell lung cancer, which ...
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 21 Jun 2025
European Medicines Agency CHMP recommends EU approval of Partner Therapeutics Imreplys (sargramostim, rhu GM-CSF) to treat exposure to myelosuppressive doses of radiation (Haematopoietic Sub-syndrome of Acute Radiation Syndrome)
20 June 2025 - Partner Therapeutics today announced that the CHMP of the EMA has recommended approval of PTx's marketing authorisation ...
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 20 Jun 2025
Zemcelpro (UM171 cell therapy) receives positive CHMP opinion for treatment of blood cancer patients without access to suitable donor cells
19 June 2025 - ExCellThera announced today the CHMP of the EMA has adopted a positive opinion, recommending granting conditional marketing ...
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 ...