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Biocon Biologics
NEWS

Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara) 

Shots:  The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab)  Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen  Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis,…
December 1, 2024

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BridgeBio
NEWS

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM 

Shots:    The US FDA has approved Attruby (oral stabilizer of Transthyretin) to reduce cardiovascular death & associated hospitalization in ATTR-CM patients. The MAA is also under review in the EU, with decision anticipated in 2025  Approval was based on P-III (ATTRibute-CM) study of Attruby vs PBO in ATTR-CM patients (n=632). It achieved its 1EP, showing…
November 22, 2024

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AOP health
INSIGHTS+

AOP Health’s Rapiblyk (landiolol) Receives the US FDA’s Approval for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting 

Shots:    The US FDA has granted approval to Rapiblyk for treating severe heart condition supraventricular tachycardia (atrial fibrillation and atrial flutter) in critical care setting  Approval was supported by 5 clinical trials assessing the safety & efficacy of Rapiblyk (9.3 to 74.6 mcg/kg/min) vs PBO in adults (n=317) with supraventricular tachycardia, showing 40-90% vs 0-11%…
November 22, 2024

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Jazz Pharmaceuticals
INSIGHTS+

Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary Tract Cancer (BTC) 

Shots:    The US FDA’s accelerated approval of Ziihera (50mg/mL, IV) was based on P-IIb (HERIZON-BTC-01) study in patients (n=87) with HER2+, locally advanced unresectable or metastatic BTC across 2 arms, based on tumor IHC status  Efficacy in 62 HER2+ BTC patients (arm 1 of HERIZON-BTC-01) showed a 52% ORR & 14.9mos. mDoR. Continued approval depends…
November 20, 2024

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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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