MicuRx Pharmaceutical’s MRX-5 Secures the US FDA’s Orphan Drug Designation for Treating NTM Infections

Shots: The US FDA has granted orphan drug designation (ODD) to MRX-5 for treating non-tuberculous mycobacteria (NTM) infections MRX-5 is a new drug for drug-resistant NTM infections, showing strong antibacterial activity, favorable safety & PK profile in both animal studies & human trial. With minimal interactions, low resistance potential & high oral bioavailability, it…

BySenior EditorJanuary 2, 2025

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HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification

Shots: The NMPA has accepted and granted priority review to NDA of Orpathys (savolitinib) + Tagrisso (osimertinib) for treating locally advanced or metastatic EGFR-mutated NSCLC with MET amplification in patients progressed on 1L EGFR inhibitor therapy. HUTCHMED will receive milestone from AstraZeneca Submission was based on P-III (SACHI) study assessing the safety & efficacy…

ByRidhi RastogiJanuary 2, 2025

NEWS

Corcept Therapeutics Reports NDA Submission of Relacorilant to the US FDA for Treating Hypercortisolism

Shots: Corcept has submitted NDA of relacorilant to the US FDA for the treatment of endogenous hypercortisolism (Cushing’s syndrome) Submission was based on pivotal GRACE study, confirmatory P-III (GRADIENT) & long-term extension trials plus P-II hypercortisolism trial. Relacorilant showed improved symptoms without adrenal insufficiency, hypokalemia, QT prolongation, or progesterone receptor-related AEs (endometrial thickening or…

ByDipanshu DixitJanuary 1, 2025

NEWS

BMS’ Opdivo Qvantig SC Injection Secures the US FDA’s Approval for Solid Tumor Opdivo Indications

Shots: The US FDA has approved Opdivo Qvantig (nivolumab & hyaluronidase-nvhy) SC injection for previously approved solid tumor Opdivo indications, incl. as monotx., maintenance therapy after Opdivo-Yervoy combination & with CT or cabozantinib Approval was based on P-III (CheckMate-67T) study assessing Opdivo Qvantig (nivolumab: 1,200mg & hyaluronidase: 20,000 units, SC, Q4W; n=248) vs Opdivo (3mg/kg,…

ByDipanshu DixitDecember 27, 2024

NEWS

BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers

Shots: The US FDA has approved Tevimbra + Pt & fluoropyrimidine-based CT as a 1L treatment of inoperable or metastatic HER2- G/GEJ adenocarcinoma with PD-L1 (≥1) expression. Another BLA for 1L locally advanced unresectable or metastatic ESCC is under review Approval was based on P-III (RATIONALE-305) study of Tevimbra + CT vs PBO in patients…

ByDipanshu DixitDecember 26, 2024

NEWS

Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors

Shots: The US FDA has approved Alhemo injection (QD) as a prophylactic treatment to reduce the frequency of bleeding episodes in hemophilia A or B patients (≥12yrs.) with inhibitors Approval was based on the P-III (explorer7) study assessing Alhemo's efficacy and safety by comparing annual bleeding rates (ABR) in patients aged 12+ with hemophilia A…

ByDipanshu DixitDecember 20, 2024

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The US FDA Approves Vertex’s Alyftrek for the Treatment of Cystic Fibrosis

Shots: The US FDA has approved Alyftrek (QD, CFTR modulator) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one F508del mutation or another CFTR gene mutation. Submissions are under review in the EU, UK, Canada, Switzerland, Australia & New Zealand Approval was supported by pivotal P-III CF program involving >1,000 patients across…

ByDipanshu DixitDecember 20, 2024

NEWS

Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS)

Shots: The US FDA has approved Tryngolza (80mg, QM, self-administered via an auto-injector) as an adj. for reducing triglycerides (TG) in FCS patients, based on a P-III (BALANCE) study. Further submission is under review in the EU, with more filings planned The P-III study involved FCS patients with fasting TG levels of ≥880mg/dL. Trial showed…

ByDipanshu DixitDecember 19, 2024

NEWS

Xcovery Holdings Receives US FDA Approval for Ensacove (Ensartinib) to Treat ALK-Positive Locally Advanced or Metastatic NSCLC

Shots: Xcovery Holdings has received the US FDA’s approval for Ensacove (225mg, oral, QD) for ALK+, locally advanced or metastatic NSCLC in patients not previously treated with ALK-targeted therapy Approval was based on a global P-III (eXalt3) study assessing ensartinib vs crizotinib in 290 patients, demonstrating significantly improved PFS with mPFS of 25.8 vs 12.7mos.…

ByDipanshu DixitDecember 18, 2024

NEWS

Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD)

Shots: The US FDA has approved Nemluvio + TCS ± calcineurin inhibitors (TCI) to treat mod. to sev. atopic dermatitis in patients unresponsive to topical therapies Approval was based on the P-III (ARCADIA) study of the combination vs PBO in patients (n=1,728; ≥12yrs.), showing significant skin clearance in both co-1EPs of IGA score (0/1) &…

ByDipanshu DixitDecember 13, 2024

MicuRx Pharmaceutical’s MRX-5 Secures the US FDA’s Orphan Drug Designation for Treating NTM Infections

HUTCHMED Reports the NMPA’s NDA Acceptance of Orpathys Plus Tagrisso with Priority Review for EGFR-Mutated NSCLC with MET Amplification

Corcept Therapeutics Reports NDA Submission of Relacorilant to the US FDA for Treating Hypercortisolism

BMS’ Opdivo Qvantig SC Injection Secures the US FDA’s Approval for Solid Tumor Opdivo Indications

BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers

Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors

The US FDA Approves Vertex’s Alyftrek for the Treatment of Cystic Fibrosis

Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS)

Xcovery Holdings Receives US FDA Approval for Ensacove (Ensartinib) to Treat ALK-Positive Locally Advanced or Metastatic NSCLC

Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD)

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