Blog
RSS FeedPosted by Michael Wonder on 09 Jun 2023
US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Pfizer’s Braftovi (encorafenib) in combination with cetuximab to identify patients with BRAF V600E alterations in metastatic colorectal cancer
9 June 2023 - Foundation Medicine today announced that it has received approval from the US FDA for FoundationOne Liquid ...
Posted by Michael Wonder on 08 Jun 2023
Novaliq announces FDA approval of Vevye (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease
8 June 2023 - Vevye is the first and only cyclosporine solution indicated for the treatment of signs and symptoms ...
Posted by Michael Wonder on 06 Jun 2023
US FDA approves new indication for Merck’s Prevymis (letermovir) for prevention of cytomegalovirus disease in high-risk adult kidney transplant recipients
6 June 2023 - Prevymis now approved for cytomegalovirus (CMV) prophylaxis after kidney transplant in donor CMV seropositive/recipient CMV seronegative ...
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 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
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. ...
Posted by Michael Wonder on 29 May 2023
Lexicon announces FDA approval of Inpefa (sotagliflozin) for treatment of heart failure
26 May 2023 - Inpefa granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and ...
Posted by Michael Wonder on 25 May 2023
FDA approves first oral anti-viral for treatment of COVID-19 in adults
25 May 2023 - Today, the US FDA approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral ...
Posted by Michael Wonder on 25 May 2023
Celltrion USA announces US FDA approval of Yuflyma (adalimumab-aaty), a high concentration and citrate free formulation of Humira (adalimumab) biosimilar
24 May 2023 - Yuflyma is FDA approved to treat eight conditions including Crohn’s disease and ulcerative colitis. ...
Posted by Michael Wonder on 23 May 2023
US FDA approves the Cyltezo Pen, a new auto-injector option, ahead of 1 July commercial launch
22 May 2023 - Cyltezo (adalimumab-adbm) will be commercially available in the US beginning on 1 July 2023. ...
Posted by Michael Wonder on 23 May 2023
FDA approves new treatment for pneumonia caused by certain difficult to treat bacteria
23 May 2023 - Today, the US FDA approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired ...
Posted by Michael Wonder on 23 May 2023
FDA approves prescription nasal spray to reverse opioid overdose
22 May 2023 - Nalmefene hydrochloride product in nasal spray form provides additional tool for harm reduction groups and first responders. ...
Posted by Michael Wonder on 23 May 2023
FDA approves new buprenorphine treatment option for opioid use disorder
23 May 2023 - Today, the US FDA approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat ...
Posted by Michael Wonder on 22 May 2023
FDA approves Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis
22 May 2023 - Approval based on the positive PIONEER trial, in which once-daily Ayvakit achieved significant improvements in disease symptoms ...