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Rhythm Pharmaceuticals
NEWS

Rhythm Pharmaceuticals Reports the US FDA Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots: The US FDA has approved Imcivree for the treatment of pts (≥4yrs.) with acquired hypothalamic obesity (HO) Approval was supported by the global P-III (TRANSCEND) trial assessing setmelanotide (n=94) vs PBO (n=48) in 142 pts with acquired HO Trial met its 1EP with a 18.4% PBO-adjusted reduction in BMI, showing -15.8% vs +2.6% mean…
March 20, 2026

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NEWS

GSK Reports the US FDA Approval of Lynavoy for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: The US FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in PBC pts; regulatory reviews in the EU, UK, Canada & China are ongoing Approval was supported by P-III (GLISTEN) trial assessing Lynavoy (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus Trial met its 1EP & key 2EPs showing…
March 20, 2026

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NEWS

Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss

Shots: The US FDA has granted BDD to Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adults with prior mod. to sev. traumatic brain injury (TBI) & persistent memory deficits The SNS is a fully implantable, closed-loop neuromodulation system that records neural activity from 60 channels across four brain regions &…
March 19, 2026

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NEWS

Johnson & Johnson Reports the US FDA Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy or phototherapy Approval was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where Icotyde met all 1EP across all 4 trials (n=2,500). In the head-to-head studies, ~70% pts achieved IGA…
March 19, 2026

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Sanofi
NEWS

Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

Shots: The US FDA has granted BTD to venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3) Designation was based on the P-III (LEAP2MONO) study assessing venglustat (QD, PO) vs imiglucerase (Q2W) in 43 pts (≥12yrs.), which showed significant improvements in neurological symptoms measured by a global test scores, incl. mSARA & RBANS  Venglustat received US…
March 18, 2026

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NEWS

Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)

Shots: The US FDA has accepted the NDA of bezuclastinib for the treatment of NonAdvSM, with no advisory committee meeting planned or review issues identified yet (PDUFA: Dec 30, 2026) NDA was backed by SUMMIT trial, which met its 1 & 2EPs, showing sustained, deepening clinical benefit through 48wks., plus impact on bone mineral density…
March 18, 2026

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NEWS

Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa

Shots: The US FDA has approved Cosentyx(secukinumab) for the treatment of pts (≥12yrs., ≥30kg) with mod. to sev. hidradenitis suppurativa Approval was supported by adult clinical studies, PK modeling extrapolated from adult HS & psoriasis trials, pediatric trial data from other approved indications, & dosing analyses that showed weight-based pediatric dosing achieves exposure comparable to…
March 16, 2026

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