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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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

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Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

Shots: Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024 The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…

ByDipanshu DixitDecember 31, 2024

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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

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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

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Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia

Shots: Bio-Thera Solutions has collaborated with Tabuk Pharmaceuticals to commercialize BAT2206, biosimilar of Stelara (Ustekinumab) in Saudi Arabia The alliance will utilize Tabuk's local footprint, sales & marketing abilities, with Tabuk handling marketing, registration, manufacturing & promotion of BAT2206. Bio-Thera will manage development & supply from its Guangzhou manufacturing facilities BAT2206, a proposed biosimilar to…

ByDipanshu DixitDecember 24, 2024

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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

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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

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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

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

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

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

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

Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia

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

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