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Spotlight
9 milestones Updated September 18, 2026
Regulatory News Spotlight
FinancingSeries A
Matisse Raises €14M for Phase 2 Sepsis Drug Trial
The Dutch biotech closed the round six months after FDA cleared isupartob sodium’s IND and granted it Fast Track designation, funding a trial of a first-in-class drug that neutralizes the histones sepsis releases into the bloodstream.
Sep 18, 2026Read more
Regulatory News Spotlight
FDABreakthrough Device
CorTec Lands Second FDA Breakthrough Nod for BCI
The same fully implanted Brain Interchange hardware that is already in an FDA feasibility study for stroke rehabilitation has now earned a second Breakthrough Device Designation, this one for letting people with paralysis in all four limbs control a computer by thought.
Sep 18, 2026Read more
Regulatory News Spotlight
FDADrug approval
Scholar Rock Wins FDA Nod for First SMA Muscle Drug
ISEMBYLD (apitegromab-mstn) is designed to be added on top of an existing SMN2-targeted therapy rather than replace it, and in the pivotal SAPPHIRE trial it moved a 12-month motor-function score that placebo patients did not.
Sep 18, 2026Read more
Regulatory News Spotlight
FDADrug approval
Pharming Wins FDA Nod to Extend Joenja to Kids
The Leiden, Netherlands company’s leniolisib now covers children ages 4 to 11 weighing at least 27 kilograms with Activated PI3K-Delta Syndrome, an ultra-rare primary immunodeficiency — the first FDA-approved APDS treatment for that age group, cleared six weeks ahead of its target review date.
Sep 17, 2026Read more
Regulatory News Spotlight
CE markDevice authorization
UpFront Diagnostics Earns CE Mark for Stroke Test
The Cambridge, UK startup’s LVOne reads two blood biomarkers from a fingerstick sample to flag large-vessel-occlusion stroke before a patient reaches hospital, and is already piloting with London Ambulance Service crews across north London.
Sep 17, 2026Read more
Regulatory News Spotlight
FDA510(k) clearance
Emboline Clears FDA Hurdle for TAVR Debris Filter
The Santa Cruz, California company’s Emboliner protects the brain and the rest of the body during transcatheter aortic valve replacement, and beat the only other cleared device on technical success and debris capture in a 522-patient head-to-head trial.
Sep 17, 2026Read more
Regulatory News Spotlight
FDA510(k) clearance
Beta Bionics Wins FDA Clearance for Mint Patch Pump
The Irvine, California company becomes the second manufacturer with a cleared tubeless insulin patch pump in the United States, filed a 510(k) for its next-generation 3D Intelligence dosing algorithm the same day, and set a full U.S. launch for the first quarter of 2027.
Sep 15, 2026Read more
Regulatory News Spotlight
FDABreakthrough designation
Armata Wins Breakthrough Status for Phage Therapy AP-SA02
The Los Angeles bacteriophage developer now holds QIDP, Fast Track and Breakthrough Therapy designations for AP-SA02, an intravenous phage cocktail given alongside antibiotics for complicated Staphylococcus aureus bacteremia, on Phase 2 data showing 100% relapse-free response versus 75% on placebo.
Sep 15, 2026Read more
Regulatory News Spotlight
FDABreakthrough designation
Juniper Lands Breakthrough Status for Hypoxia PET Tracer
The New Jersey company’s F-MISO imaging agent, licensed from Memorial Sloan Kettering, maps tumor hypoxia so that patients with HPV-positive oropharyngeal cancer whose tumors are not oxygen-starved can be treated with 30 Gray instead of 70. The designation is the first for a hypoxia tracer in the United States.
Sep 15, 2026Read more
FinancingSeries A
Matisse Raises €14M for Phase 2 Sepsis Drug Trial
The Dutch biotech closed the round six months after FDA cleared isupartob sodium’s IND and granted it Fast Track designation, funding a trial of a first-in-class drug that neutralizes the histones sepsis releases into the bloodstream.
Sep 18, 2026Read more
Regulatory News Spotlight
FDABreakthrough Device
CorTec Lands Second FDA Breakthrough Nod for BCI
The same fully implanted Brain Interchange hardware that is already in an FDA feasibility study for stroke rehabilitation has now earned a second Breakthrough Device Designation, this one for letting people with paralysis in all four limbs control a computer by thought.
Sep 18, 2026Read more
Regulatory News Spotlight
FDADrug approval
Scholar Rock Wins FDA Nod for First SMA Muscle Drug
ISEMBYLD (apitegromab-mstn) is designed to be added on top of an existing SMN2-targeted therapy rather than replace it, and in the pivotal SAPPHIRE trial it moved a 12-month motor-function score that placebo patients did not.
Sep 18, 2026Read more
Regulatory News Spotlight
FDADrug approval
Pharming Wins FDA Nod to Extend Joenja to Kids
The Leiden, Netherlands company’s leniolisib now covers children ages 4 to 11 weighing at least 27 kilograms with Activated PI3K-Delta Syndrome, an ultra-rare primary immunodeficiency — the first FDA-approved APDS treatment for that age group, cleared six weeks ahead of its target review date.
Sep 17, 2026Read more
Regulatory News Spotlight
CE markDevice authorization
UpFront Diagnostics Earns CE Mark for Stroke Test
The Cambridge, UK startup’s LVOne reads two blood biomarkers from a fingerstick sample to flag large-vessel-occlusion stroke before a patient reaches hospital, and is already piloting with London Ambulance Service crews across north London.
Sep 17, 2026Read more
Regulatory News Spotlight
FDA510(k) clearance
Emboline Clears FDA Hurdle for TAVR Debris Filter
The Santa Cruz, California company’s Emboliner protects the brain and the rest of the body during transcatheter aortic valve replacement, and beat the only other cleared device on technical success and debris capture in a 522-patient head-to-head trial.
Sep 17, 2026Read more
Regulatory News Spotlight
FDA510(k) clearance
Beta Bionics Wins FDA Clearance for Mint Patch Pump
The Irvine, California company becomes the second manufacturer with a cleared tubeless insulin patch pump in the United States, filed a 510(k) for its next-generation 3D Intelligence dosing algorithm the same day, and set a full U.S. launch for the first quarter of 2027.
Sep 15, 2026Read more
Regulatory News Spotlight
FDABreakthrough designation
Armata Wins Breakthrough Status for Phage Therapy AP-SA02
The Los Angeles bacteriophage developer now holds QIDP, Fast Track and Breakthrough Therapy designations for AP-SA02, an intravenous phage cocktail given alongside antibiotics for complicated Staphylococcus aureus bacteremia, on Phase 2 data showing 100% relapse-free response versus 75% on placebo.
Sep 15, 2026Read more
Regulatory News Spotlight
FDABreakthrough designation
Juniper Lands Breakthrough Status for Hypoxia PET Tracer
The New Jersey company’s F-MISO imaging agent, licensed from Memorial Sloan Kettering, maps tumor hypoxia so that patients with HPV-positive oropharyngeal cancer whose tumors are not oxygen-starved can be treated with 30 Gray instead of 70. The designation is the first for a hypoxia tracer in the United States.
Sep 15, 2026Read more
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