Shots:
The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed
iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed…
NEWS
Shots:
Sino Biopharmaceutical has entered into an exclusive license agreement with AstraZeneca for the development, manufacturing & commercialization of TQC3721, an inhaled PDE3/4 inhibitor
As per the deal, AstraZeneca secured exclusive rights to develop, manufacture, & commercialize TQC3721 outside China, along with exclusive global rights to select future development programs
In return, Sino will receive…
Shots:
The US FDA has accepted the NDA for Immunome’s varegacestat for the treatment of adults with desmoid tumors, with a PDUFA target action date of Apr 28, 2027
NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid…
Shots:
Insilico has initiated a P-III trial assessing Rentosertib vs PBO in ~320 pts with idiopathic pulmonary fibrosis (IPF) over 52wks.
Earlier P-IIa (GENESIS-IPF) trial data showed Rentosertib (30mg, QD or BID, & 60mg, QD) met its 1EP, plus 60mg arm demonstrated a mean FVC change of +98.4mL vs -20.3mL at 12wks.
Rentosertib, an oral…
Shots:
Biocytogen has entered into a global collaboration with Whitehawk Therapeutics to develop bispecific antibody-drug conjugates (BsADCs)
Biocytogen will provide ~5 bispecific antibodies from its RenLite platform & Whitehawk will evaluate these in combination with its ADC linker-payload technologies, with Whitehawk holding the option to advance resulting BsADC candidates
Biocytogen will receive an upfront payment,…
Shots:
Longeviti Neuro has launched ClearFit AI, a Brain Ultrasound Interface, creating a persistent acoustic window to the brain to enable real-time bedside ultrasound imaging after neurosurgery
ClearFit AI combines sonolucent cranial implants, ultrasound compatibility, clinical workflow support, & AI-enhanced imaging to enable bedside brain assessment within existing neuro care workflows, potentially reducing CT/MRI transport…
Shots:
OTR has partnered with LG Chem to identify, evaluate & develop novel oncology assets from China, leveraging OTR's R&D platform & LG Chem's global development expertise & commercial infrastructure
As per the deal, OTR will identify & advance oncology assets through early clinical development in China, while LG Chem will jointly evaluate & license…
Shots:
The US FDA has granted accelerated approval to Trutakna to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression
Approval was supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in adults with IgAN, assessing eGFR-based kidney function over 2yrs., with…
Shots:
The US FDA has accepted the sNDA & granted priority review to mitapivat, under FDA’s accelerated approval pathway, for the treatment of Sickle Cell Disease (PDUFA: Nov 1, 2026)
sNDA was supported by the global P-II/III (RISE UP) trial assessing mitapivat (100mg, PO, BID; n=138) vs PBO (n=69) in 207 pts with SCD (≥16yrs.)…
Shots:
Splash secured exclusive global rights to develop & commercialize CannEpil for drug-resistant epilepsy, refractory epilepsy, seizure disorders, & related neurological conditions, incl. future product improvements & next-generation formulations
Splash secured a $1M strategic investment from C/M Capital Partners, while Mercer Street forgave ~$5M in Argent BioPharma debt and Splash issued $5.5M in preferred equity…

