Changes to the Regulatory Landscape, and what they mean.
The Ann Arbor biotech closed a $123 million Series C on 16 September 2026, led by Forbion, to carry linsitinib — an oral pill it says is the only IGF-1R inhibitor in late-stage development for thyroid eye disease — through its pivotal ORBIT trial and toward a filing that would challenge Amgen's infused Tepezza.
Spotlight
The Paris company's EG110A, a one-time injection that silences the sensory nerves behind neurogenic detrusor overactivity after spinal cord injury, now holds Regenerative Medicine Advanced Therapy designation on the strength of an 88% drop in incontinence episodes — its third FDA designation in under a year.
Drugs & Biologics
The EU committee's positive opinion for gefurulimab, a dual-binding nanobody dosed by weekly self-injection, would give generalised myasthenia gravis patients a complement inhibitor that skips the infusion chair — one of twelve new medicines the same September plenary recommended.
Drugs & Biologics
A full approval pairs Lilly's oral SERD Inluriyo with its CDK4/6 inhibitor Verzenio for ESR1-mutated, ER-positive breast cancer, doubling median progression-free survival over Inluriyo alone in the pivotal subgroup — and arrives alongside an expanded companion diagnostic clearance for Guardant360 CDx.
Guidance & Policy
A new draft guidance would give Premarket Approval sponsors a standardized, eSTAR-based electronic template — the same guided-submission format FDA has already made mandatory for most 510(k)s and De Novo requests. Comments on the class III pathway's turn close 17 November.
Clearances, approvals, financings and launches — the companies getting the go-ahead.
All spotlights →Sling Therapeutics
The Ann Arbor biotech closed a $123 million Series C on 16 September 2026, led by Forbion, to carry linsitinib — an oral pill it says is the only IGF-1R inhibitor in late-stage development for thyroid eye disease — through its pivotal ORBIT trial and toward a filing that would challenge Amgen's infused Tepezza.
Cyllene Therapeutics
The Paris company's EG110A, a one-time injection that silences the sensory nerves behind neurogenic detrusor overactivity after spinal cord injury, now holds Regenerative Medicine Advanced Therapy designation on the strength of an 88% drop in incontinence episodes — its third FDA designation in under a year.
RegCell
The Emeryville, California company’s $44 million Series A and a second non-dilutive grant from Japan’s AMED will fund an FDA IND submission and a second autoimmune program for the cell therapy platform built on Shimon Sakaguchi’s Nobel-winning regulatory T-cell science.
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