Blog
RSS FeedPosted by Michael Wonder on 06 Jun 2023
SpringWorks Therapeutics announces PDUFA date extension for nirogacestat NDA
5 June 2023 - FDA extending PDUFA date by three months to allow more time to complete their review; new ...
Posted by Michael Wonder on 06 Jun 2023
Injectafer approved in the US for the treatment of iron deficiency in adult patients with heart failure
5 June 2023 - Injectafer is now the first and only intravenous iron replacement therapy indicated for adult patients with heart ...
Posted by Michael Wonder on 05 Jun 2023
FDA considers temporary cancer drug imports from unapproved companies to ease US shortage
1 June 2023 - Shortages of cisplatin and carboplatin have forced some hospitals to ration the drugs by reducing doses to ...
Posted by Michael Wonder on 05 Jun 2023
Mark Cuban Cost Plus Drug Company joins forces with Coherus to make Yusimry, a Humira biosimilar, available to patients
1 June 2023 - YUSIMRY will be available on costplusdrugs.com for $569.27 plus dispensing and shipping fees. ...
Posted by Michael Wonder on 02 Jun 2023
Coherus announces industry wide lowest list price for adalimumab biosimilar Yusimry (adalimumab-aqvh) launching in July 2023
1 June 2023 - List price of $995 per carton for two 40 mg/0.8 mL auto-injectors. ...
Posted by Michael Wonder on 02 Jun 2023
Esperion announces submission of supplemental new drug applications to US FDA for Nexletol (bempedoic acid) tablet and Nexlizet (bempedoic acid and ezetimibe) tablet
1 June 2023 - Submitted four efficacy supplements seeking inclusion of cardiovascular disease risk reduction and expansion of LDL-cholesterol lowering. ...
Posted by Michael Wonder on 02 Jun 2023
Pharming announces sale of priority review voucher
1 June 2023 - Pharming announces that it has entered into a definitive agreement with Novartis to sell its rare ...
Posted by Michael Wonder on 02 Jun 2023
FDA considers new efficacy endpoint for diabetes drugs
31 May 2023 - The US FDA on Friday released an updated draft guidance to help sponsors demonstrate efficacy for ...
Posted by Michael Wonder on 02 Jun 2023
Kyverna Therapeutics granted FDA fast track designation for KYV-101 in lupus nephritis
1 June 2023 - KYV-101 is a novel, fully human anti-CD19 chimeric antigen receptor T-cell therapy designed to deplete B cells, ...
Posted by Michael Wonder on 01 Jun 2023
Arcturus Therapeutics receives US FDA fast track designation for ARCT-810, mRNA therapeutic candidate for ornithine transcarbamylase deficiency
1 June 2023 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation to ARCT-810, the Company’s ...
Posted by Michael Wonder on 01 Jun 2023
US FDA approves Abrysvo, Pfizer’s vaccine for the prevention of respiratory syncytial virus in older adults
31 May 2023 - FDA’s decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 ...
Posted by Michael Wonder on 31 May 2023
FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA mutated metastatic castration-resistant prostate cancer
31 May 2023 - Today, the FDA approved olaparib (Lynparza, AstraZeneca Pharmaceuticals) with abiraterone and prednisone (or prednisolone) for adult ...
Posted by Michael Wonder on 30 May 2023
A short supply of cancer drugs has doctors and patients worried: 'we're at a critical juncture'
30 May 2023 - A drug shortage is forcing doctors to reduce doses of chemotherapy. ...
Posted by Michael Wonder on 30 May 2023
Inhibrx granted fast track designation for INBRX-101 for the treatment of alfa-1 antitrypsin deficiency
30 May 2023 - Inhibrx announced today that the US FDA granted fast track designation to INBRX-101, an optimised recombinant ...
Posted by Michael Wonder on 30 May 2023
US FDA approves Blue Earth Diagnostics’ Posluma (flotufolastat F 18) injection, first radiohybrid PSMA targeted PET imaging agent for prostate cancer
30 May 2023 - Posluma will be commercially available in the United States in early June 2023. ...