Regulation

Takeda gets approval for acute lymphoblastic leukemia treatment sNDA

Takeda has received accelerated approval for a supplemental new drug application (sNDA) from the US Food and Drug Administration (FDA) for ICLUSIG (ponatinib) to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

FDA committee recommends BMS-2seventy’s Abecma

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.

Johnson & Johnson files sBLA for ulcerative colitis treatment

Johnson & Johnson has filed a supplemental biologics license application (sBLA) with the US Food and Drug Administration (FDA) seeking approval for TREMFYA (guselkumab)to treat moderately to severely active ulcerative colitis (UC).

iOnctura receives orphan drug status for pancreatic cancer therapy

iOnctura has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its autotaxin inhibitor, cambritaxestat, for pancreatic cancer.

UK NICE recommends GSK’s Dostarlimab regimen for womb cancer

The UK National Institute for Health and Care Excellence (NICE) has recommended GSK’s Dostarlimab, marketed as Jemperli, for use with chemotherapy in treating specific advanced or recurrent womb cancers.

FDA approves Formosa-AimMax’s post-surgery eye care treatment

The US Food and Drug Administration (FDA) has granted approval to Formosa Pharmaceuticals and AimMax Therapeutics’ clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation and pain after ocular surgical procedure.

EMA validates Daiichi Sankyo-AstraZeneca’s cancer therapy applications

The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan (Dato-DXd) for two types of cancer.

EMA CHMP provides positive opinion for Janssen’s multiple myeloma therapy

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided positive opinion for the Janssen Pharmaceutical Companies of Johnson & Johnson’s CARVYKTI (cilta-cel) for earlier stage of relapsed and refractory multiple myeloma (RRMM) treatment.

Japan grants priority review for Astellas’ urothelial cancer regimen

Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for Astellas Pharma’s supplemental new drug application (sNDA) for PADCEV (enfortumab vedotin) and KEYTRUDA (pembrolizumab) combination to treat urothelial cancer.