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RSS FeedPosted by Michael Wonder on 16 Apr 2026
Opna Bio announces fast track designation granted to OPN-6602 for the treatment of multiple myeloma
15 April 2026 - Opna Bio today announced that the US FDA has granted fast track designation to OPN-6602, a dual ...
Posted by Michael Wonder on 15 Apr 2026
Partner Therapeutics announces submission of supplemental biologics license application to FDA for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
14 April 2026 - Partner Therapeutics announces the submission of a supplemental biologics license application to the US FDA for Bizengri ...
Posted by Michael Wonder on 15 Apr 2026
Renaissance Pharma secures FDA fast track designation for daretabart (hu1418K322A) in high risk neuroblastoma
14 April 2026 - Renaissance Pharma Limited, an Essential Pharma company, today announces that the US FDA has granted fast track ...
Posted by Michael Wonder on 10 Apr 2026
Celltrion’s ADC candidate CT-P71 wins FDA fast track in urothelial cancer
9 April 2026 - Celltrion announced Thursday that the US FDA has granted fast track designation to its antibody-drug conjugate ...
Posted by Michael Wonder on 07 Apr 2026
NextCure receives fast track designation for SIM0505 (CDH6 ADC) in ovarian cancer
7 April 2026 - NextCure today announced that the US FDA has granted fast track designation for SIM0505 for the ...
Posted by Michael Wonder on 07 Apr 2026
Nuvalent announces submission of new drug application to FDA for neladalkib in TKI pre-treated advanced ALK positive NSCLC
7 April 2026 - New drug application based on data in TKI pre-treated patients from the global ALKOVE-1 Phase 1/2 ...
Posted by Michael Wonder on 03 Apr 2026
Context Therapeutics announces CTIM-76 receives FDA fast track designation for the treatment of platinum-resistant ovarian cancer
2 April 2026 - Context Therapeutics today announced that the US FDA has granted fast track designation to CTIM-76, a ...
Posted by Michael Wonder on 02 Apr 2026
Fore Biotherapeutics receives breakthrough therapy designation for plixorafenib
1 April 2026 - Fore Biotherapeutics today announced that the US FDA has granted breakthrough therapy designation to plixorafenib for the ...
Posted by Michael Wonder on 02 Apr 2026
A2 Biotherapeutics receives US FDA fast track designation for A2B543, a logic-gated CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster
1 April 2026 - A2 Biotherapeutics today announced that the US FDA has granted fast track designation for A2B543, an autologous ...
Posted by Michael Wonder on 31 Mar 2026
Zymeworks receives US FDA fast track designation for ZW191, a folate receptor alfa targeting antibody drug conjugate
30 March 2026 - Zymeworks today announced that the US FDA has granted fast track designation to ZW191, an antibody ...
Posted by Michael Wonder on 30 Mar 2026
Elevar Therapeutics announces FDA acceptance for review of new drug application for lirafugratinib as second-line cholangiocarcinoma treatment
30 March 2026 - Elevar Therapeutics today announced that the US FDA has completed its filing review of the new drug ...
Posted by Michael Wonder on 25 Mar 2026
Triana Biomedicines’ TRI-611 granted US FDA fast track designation for treatment of ALK positive non-small cell lung cancer
25 March 2026 - Triana Biomedicines today announced that the US FDA granted fast track designation for TRI-611, an investigational molecular ...
Posted by Michael Wonder on 25 Mar 2026
FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
25 March 2026 - Today, the FDA approved relacorilant (Lifyorli, Corcept Therapeutics), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel ...
Posted by Michael Wonder on 20 Mar 2026
Bristol Myers Squibb transforms the classical Hodgkin lymphoma treatment paradigm with expanded US and EMA approvals for Opdivo (nivolumab)
20 March 2026 - Bristol Myers Squibb today announced that Opdivo (nivolumab) has received approval for two new classical Hodgkin ...
Posted by Michael Wonder on 20 Mar 2026
FDA approves nivolumab with chemotherapy for previously untreated Hodgkin lymphoma
20 March 2026 - Today, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with doxorubicin, vinblastine, and dacarbazine for ...