RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Shots: The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025 The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food…

ByRidhi RastogiSeptember 30, 2025

NEWS

Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

Shots: FDA has approved Tremfya (SC; Wk. 0, 4 & then Q8W) for children (≥6yrs.; ≥40kg) with mod. to sev. plaque PsO, who are candidates for systemic therapy or phototherapy, or active PsA; an FDA application was also filed to add joint damage inhibition in active PsA adults to Tremfya’s label Plaque PsO approval was based…

ByRidhi RastogiSeptember 30, 2025

NEWS

Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)

Shots: The US FDA has approved Enoby (RGB-14-P) & Xtrenbo (RGB-14-X), biosimilar versions of Prolia & Xgeva (denosumab) for the treatment of bone & skeletal disorders Approval was based on extensive clinical data submitted by Hikma, incl. analytical, non-clinical & clinical studies, which showed comparable quality, efficacy, safety & immunogenicity of Enoby & Xtrenbo to reference…

ByRidhi RastogiSeptember 29, 2025

NEWS

AbbVie Reports the US FDA’s NDA submission of Tavapadon to Treat Parkinson’s Disease

Shots: The US FDA has received an NDA for tavapadon (QD, PO) for Parkinson’s disease (PD), supported by P-III (TEMPO-1 & 2) trials in early PD & P-III (TEMPO-3) evaluating adjunctive use with levodopa in pts with motor fluctuations, plus interim data from P-III (TEMPO-4) open label study TEMPO-1 (n=529) & TEMPO-2 (n=304) evaluated fixed…

ByRidhi RastogiSeptember 29, 2025

NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…

ByRidhi RastogiSeptember 29, 2025

NEWS

Regeneron’s Evkeeza Receives the US FDA’s Approval to Treat Homozygous Familial Hypercholesterolemia in Younger Patients

Shots: The US FDA has approved label expansion to Evkeeza (evinacumab-dgnb) as an adj. to diet, exercise & other lipid-lowering therapies for the treatment of children (1 to <5yrs.) with homozygous familial hypercholesterolemia (HoFH) Approval was supported by efficacy & safety results in 6 children with HoFH (incl. PK data from 4) who participated in…

ByRidhi RastogiSeptember 29, 2025

NEWS

HemoSonics Secures the US FDA’s 510(k) Clearance for Quantra Hemostasis System in Obstetric Procedures

Shots: The US FDA has granted 510(k) clearance to Quantra Hemostasis System with QStat Cartridge, expanding its use in peripartum obstetric procedures to help manage postpartum hemorrhage Quantra is a cartridge-based viscoelastic testing system that uses SEER Sonorheometry tech to provide fast, point-of-care whole-blood coagulation analysis in <15min., enabling individualized & evidence-based decisions, along with…

ByRidhi RastogiSeptember 26, 2025

NEWS

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Shots: FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks. Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane…

ByRidhi RastogiSeptember 26, 2025

NEWS

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

Shots: The US FDA has approved Palsonify for 1L treatment of adults with acromegaly who are ineligible for or inadequately respond to surgery; commercially available in the US by Oct 2025 & MAA under EMA's review, with CHMP opinion expected in H1’26 Approval was based on 2 P-III (PATHFNDR-2 & PATHFNDR-1) trials assessing Palsonify vs PBO…

ByRidhi RastogiSeptember 26, 2025

NEWS

ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Shots: ClearNote Health has received the UKCA certification for its Avantect Multi-Cancer & Ovarian Cancer tests to detect multiple cancers & support early diagnosis of ovarian cancer, respectively The Multi-Cancer Detection Test screens multiple cancers from a simple blood sample using 5-hydroxymethylcytosine & genomic biomarkers in cell-free DNA, & was selected for the NCI-funded Vanguard…

ByRidhi RastogiSeptember 25, 2025

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis

Gedeon Richter and Hikma Pharmaceuticals Receive the US FDA’s Approval for Enoby and Xtrenbo (Biosimilar, Prolia & Xgeva)

AbbVie Reports the US FDA’s NDA submission of Tavapadon to Treat Parkinson’s Disease

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Regeneron’s Evkeeza Receives the US FDA’s Approval to Treat Homozygous Familial Hypercholesterolemia in Younger Patients

HemoSonics Secures the US FDA’s 510(k) Clearance for Quantra Hemostasis System in Obstetric Procedures

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Crinetics Pharmaceuticals Reports the US FDA’s Approval of Palsonify (Paltusotine) for Acromegaly

ClearNote Health Receives UKCA Marking for its Avantect Multi-Cancer & Ovarian Cancer Detection Tests

Contact US

OUR INFORMATION

FOLLOW US