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Iterum Therapeutics
NEWS

Iterum Therapeutics’ Orlynvah (Oral Sulopenem) Receives the US FDA’s Approval to Treat uUTIs 

Shots:    The US FDA has approved Orlynvah (sulopenem etzadroxil & probenecid) to treat uUTIs in adult women, specifically addressing infections caused by E.coli, Klebsiella pneumoniae, or Proteus mirabilis, particularly when there are few or no other oral therapy available  Approval was based on two pivotal P-III studies (SURE 1 & REASSURE) that assessed the safety…
October 25, 2024

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Pfizer
NEWS

Pfizer Reports the US FDA’s Approval of Hympavzi to Treat Hemophilia A/B without Inhibitors in Adults and Adolescents 

Shots:    The US FDA has approved Hympavzi (QW, SC) as a prophylactic treatment to prevent bleeding episodes in patients (≥12yrs.) with hemophilia A & B without FVIII & FIX inhibitors, respectively. It has also received the CHMP’s positive opinion for the same  Results from pivotal P-III (BASIS) study, assessing Hympavzi in patients (12-75yrs.) with severe…
October 11, 2024

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Roche
NEWS

Roche’s Reports the US FDA’s Approval of Itovebi as a Treatment for HR+ and HER2- breast cancer with a PIK3CA mutation 

Shots:    The US FDA approved Itovebi + Ibrance & fulvestrant as a 1L treatment in adults with endocrine-resistant, PIK3CA-mutated, HR+ & HER2- locally advanced or metastatic breast cancer, based on the P-III (INAVO120) trial  P-III (INAVO120) trial assessed the safety and efficacy of Itovebi + Ibrance & fulvestrant vs PBO + Ibrance & fulvestrant (n=…
October 11, 2024

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Teva
NEWS

Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA 

Shots:  The US FDA and the EMA has accepted Teva’s applications for TVB-009P, biosimilar version of Prolia (denosumab), for all the approved indications, with their decisions anticipated during H2’25  Submissions were built upon the data from P-III (TVB009-IMB-30085) study assessing safety & efficacy of TVB-009P vs Prolia among women with postmenopausal osteoporosis as well as…
October 8, 2024

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GE HealthCare
NEWS

GE HealthCare Reports the US FDA’s Approval of Flyrcado (Flurpiridaz F 18) PET Radiotracer for Improved CAD Diagnosis 

Shots:     The US FDA has approved Flyrcado injection as a PET MPI agent to diagnose CAD, with its launch planned in early 2025   The effectiveness of Flyrcado  was assessed under the P-III (AURORA) study in comparison with both invasive coronary angiography as a standard and SPECT MPI to identify CAD    In addition, GE HealthCare secured…
September 27, 2024

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Bristol Myers Squibb
NEWS

BMS’ Cobenfy (Xanomeline and Trospium Chloride) Receives the US FDA Approval for Treating Schizophrenia 

Shots:     The US FDA has granted approval to BMS’ Cobenfy for treating schizophrenia in adults, based on its EMERGENT studies  The EMERGENT studies comprised of P-III (EMERGENT-2 & 3) trials, evaluating the safety, efficacy & tolerability of Cobenfy vs PBO in schizophrenic adults for over 5wks., as well as two open-label trials assessing long-term safety…
September 26, 2024

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IntraBio
NEWS

IntraBio’s Aqneursa Receives the US FDA’s Approval for Treating Niemann-Pick Disease Type C 

Shots:     The US FDA has granted approval to Aqneursa (levacetylleucine) for treating adults & pediatric patients (≥15kg) with neurological manifestations of Niemann-Pick disease type C (NPC)  Approval was supported by pivotal P-III (IB1001-301) study assessing the effect of Aqneursa vs PBO on neurological symptoms & functioning in pediatric (≥4yrs.) & adults (n=60) with confirmed NPC …
September 25, 2024

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Zevra Therapeutics
NEWS

Zevra Therapeutics Receives the US FDA’s Approval of Miplyffa (Arimoclomol Citrate) for Treating Niemann-Pick Disease Type C (NPC) 

Shots:     The US FDA has awarded priority review voucher & approved Miplyffa (47mg to 124mg, oral, TID) + miglustat to treat neurological manifestations in adults & pediatrics (≥2yrs.) with NPC, with its launch planned within 8-12wks.    Approval was based on trial of Miplyffa + miglustat vs PBO in NPC patients (2-19yrs.), showing halted disease progression…
September 20, 2024

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Accord Healthcare
NEWS

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

Shots:  The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025  The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the…
September 18, 2024

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