Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

Shots: The US FDA has granted 510(k) clearance to CardioTag device for assessing cardiac function Upon regulatory approval for the PCWP Analysis Software, the algorithm will be integrated with the CardioTag device for advanced heart failure management, following a multicenter study showing its PCWP value estimates matched implantable hemodynamic sensor accuracy in HFrEF pts; data was published…

ByRidhi RastogiJuly 31, 2025

NEWS

Apellis Pharmaceuticals Reports the US FDA’s Approval of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

Shots: The US FDA has approved Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.) Approval was based on P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all pts received Empaveli Trial met…

ByRidhi RastogiJuly 30, 2025

NEWS

PTC Therapeutics Receives the US FDA’s Approval for Sephience to Treat Phenylketonuria

Shots: The US FDA has approved Sephience (sepiapterin) for the treatment of phenylketonuria (PKU) in pts of all ages, with broad labeling for hyperphenylalaninemia in adults & pediatric pts (≥1mos.) with sepiapterin-responsive PKU; review is ongoing in Japan & Brazil Approval was based on APHENITY study results & long-term extension data showing durable effects and…

ByRidhi RastogiJuly 29, 2025

NEWS

Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia

Shots: The US FDA has approved Doptelet to treat thrombocytopenia in pts (≥1yrs.) with persistent or chronic ITP who have not responded to prior treatments. Approval also incl. a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for children (1-6yrs.) Approval was based on P-III (AVA-PED-301) study assessing Doptelet in pediatric ITP pts, which showed that…

ByRidhi RastogiJuly 28, 2025

NEWS

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

Shots: Minnesota Medical Technologies has reported the US FDA’s 510(k) clearance to StaySure for the management of fecal incontinence (FI) A completed clinical trial demonstrated the device’s safety & efficacy, with a reduction in fecal incontinence frequency & improved QoL; full results are expected later in 2025 StaySure, marketed as Navina Insert in the EU, is…

ByRidhi RastogiJuly 25, 2025

NEWS

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Shots: The US FDA has approved Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had inadequate response or are unamenable to topical corticosteroids Approval was based on P-III (DELTA 1 & DELTA 2) trials assessing Anzupgo (BID) vs vehicle in 960 adults with mod. to sev. CHE, both of which…

ByRidhi RastogiJuly 24, 2025

NEWS

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Shots: Medtronic has received CE mark to extend label of MiniMed 780G system to pts (≥2yrs.), pregnant women & T2D pts; application is under the FDA’s review for T2D, plus US trial for use in pts (2-6yrs.) is underway Approval was backed by extensive clinical data incl. LENNY trial data in T1D pts (2–6 yrs), showing a…

ByRidhi RastogiJuly 22, 2025

NEWS

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has received NDA of icotrokinra for the treatment of pts (≥12yrs.) with mod. to sev. plaque PsO NDA was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where ICONIC-LEAD (vs PBO) met its co-1EPs of IGA 0/1 & PASI 90 at Wk. 16, plus showed higher rates of clear or almost clear…

ByRidhi RastogiJuly 22, 2025

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Merck Animal Health Reports the US FDA’s Approval of Exzolt for Northern Fowl Mites

Shots: The US FDA has approved Exzolt (fluralaner oral solution) to treat & control northern fowl mites (Ornithinyssus sylviarum) in chickens Exzolt is a parasiticide that targets the nervous system of northern fowl mites, killing those that ingest a blood meal, while remaining safe for laying hens & replacement chickens Exzolt, available in 1L &…

ByRidhi RastogiJuly 21, 2025

NEWS

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

Shots: The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601 for the treatment of PKP2-arrhythmogenic cardiomyopathy Designation was supported by ongoing P-I trial, where all 3 adults treated with a single dose of RP-A601 (8x10¹³ GC/kg) showed enhanced PKP2 protein expression, incl. 110% & 398% increase in 2 pts with low…

ByRidhi RastogiJuly 18, 2025

Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

Apellis Pharmaceuticals Reports the US FDA’s Approval of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

PTC Therapeutics Receives the US FDA’s Approval for Sephience to Treat Phenylketonuria

Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Medtronic Reports the European CE Mark of MiniMed 780G System for Automated Insulin Delivery

Johnson & Johnson Submits NDA to the US FDA for Icotrokinra to Treat Plaque Psoriasis (PsO)

Merck Animal Health Reports the US FDA’s Approval of Exzolt for Northern Fowl Mites

Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

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