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…

ByRidhi Rastogi3 days ago

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LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

Shots: Approval for adults with mod. to sev. OSA (AHI: 15–65) who failed, cannot tolerate, or are ineligible for 1L therapies, was backed by OSPREY RCT, which met its 1EPs at 6mos. (M6) vs control, showing reductions in AHI, ODI, & improved PROs in sleep disturbance In the RCT (therapy start: M1 vs M7), M12…

ByRidhi Rastogi3 days ago

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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…

ByRidhi Rastogi3 days ago

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JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: The US FDA has granted PMA approval to the Trilogy THV System to treat ssAR in pts at high or greater surgical risk, with immediate launch planned via participating study sites, followed by hospitals across the US Approval was supported by the results from ALIGN-AR pivotal IDE trial assessing safety & efficacy of the…

ByRidhi Rastogi4 days ago

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FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Asian Longhorned and Gulf Coast Tick

Shots: The US FDA has approved label expansion of Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension) for dogs to treat & control Asian longhorned tick (H. longicornis) & Gulf Coast tick (A. maculatum) for 12mos. The extended-release injectable Bravecto Quantum provides a once-yearly dosing option for improved compliance & continuous protection, & is available exclusively…

ByRidhi Rastogi4 days ago

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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…

ByRidhi Rastogi4 days ago

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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…

ByRidhi Rastogi5 days ago

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Myriad Genetics Receives the US FDA Approval for MyChoice CDx Test as a Companion Diagnostic for GSK’s Zejula

Shots: The US FDA has approved MyChoice CDx Test as a companion diagnostic for for HRD+ identification in pts with advanced ovarian cancer who may benefit from treatment with Zejula (niraparib) Approval was based on the PRIMA trial assessing Zejula vs PBO in ovarian cancer pts with complete or partial response to 1L Pt-based CT,…

ByRidhi Rastogi5 days ago

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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…

ByRidhi Rastogi5 days ago

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Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

Shots: The US FDA has granted 510(k) clearance to the Urocross Expander System for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), backed by extensive data incl. the Expander-1 & Expander-2 trials Expander-2 (n=240) showed mean 48.1% IPSS improvement & a 74.5% responder rate (≥30% IPSS reduction) at 12mos. post implantation…

ByRidhi RastogiMarch 17, 2026

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

LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

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

JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Asian Longhorned and Gulf Coast Tick

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

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

Myriad Genetics Receives the US FDA Approval for MyChoice CDx Test as a Companion Diagnostic for GSK’s Zejula

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

Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

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