Shots:
The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada
NDA was supported by P-III (APeX-P) trial assessing Orladeyo…
NEWS
Shots:
The US FDA has accepted sNDA of Filspari for the treatment of FSGS, plus FDA has planned to hold advisory committee meeting to discuss the application (PDUFA: Jan 13, 2026)
sNDA was supported by P-III (DUPLEX) trial & P-II (DUET) trial assessing Filspari vs irbesartan in FSGS pts; Pts completing the DUPLEX & DUET double-blind…
Shots:
FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under review
Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…
Shots:
Rznomics has signed a strategic global license agreement with Eli Lillyto develop & commercialize RNA-editing therapies for inherited hearing loss using Rznomics' trans-splicing ribozyme platform
As per the deal, if Lilly avail all its options then total deal value could surpass $1.3B with undisclosed upfront payment, in addition to separate royalties from product sales
The…
Shots:
ArkBio has reported positive top-line data from the P-II study conducted across 31 clinical sites in China to evaluate safety, tolerability, and clinical efficacy of AK3280 in IPF pts
Pts who received AK3280 (100/200/300/400mg BID) demonstrated 209.4 mL increase in forced vital capacity (FVC) and a 6.4% adjusted improvement in %pFVC from baseline and…
Shots:
The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC
Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…
Shots:
Merck has reported ongoing P-III (KEYNOTE-B96/ENGOT-ov65) trial findings on Keytruda for the treatment of Pt-resistant recurrent ovarian cancer
Trial assessed Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in pts (n=643)
Trial met its 1EP of improved PFS in overall population & 2EP of OS in pts…
Shots:
TelmyVet & PetPace have launched the Quality-of-Life Consultation, a virtual care service to support pets & their families during end-of-life stages
Service combines TelmyVet’s telemedicine platform with PetPace’s AI-powered smart collar, which tracks HRV, vital signs, mobility, & behavior to assess pain & stress. It offers a supportive space for pet parent guidance &…
Shots:
AbbVie has entered into collaboration & license option agreement with ADARx to develop siRNA therapeutics across multiple disease areas, incl. neuroscience, immunology & oncology, leveraging ADARx's RNA tech
As per the deal, ADARx will receive $335M upfront & will be eligible to receive several billion in additional contingent payments incl. option fees, milestones, plus tiered royalties…
Shots:
Genesys Spine has launched its Stasys-C 3DP Cervical Standalone System to simplify anterior cervical procedures
Stasys-C has a non-screw-based fixation method with quick, non-impacting anchor deployment via a direct anterior approach, plus it has Quick Turn Cam Lock, which allows visual anchor engagement & locking confirmation, while the SemaFour surface design maximizes wettability, surface…

