Blog
RSS FeedPosted by Michael Wonder on 20 Jul 2018
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukeamia who have a certain genetic mutation
20 July 2018 - The U.S. FDA today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or ...
Posted by Michael Wonder on 20 Jul 2018
FDA approves new indications for Zomacton (somatropin) as Ferring plans launch of needle-free delivery system
19 July 2018 - Ferring will launch ZOMA-Jet 10 needle-free delivery system for Zomacton in September. ...
Posted by Michael Wonder on 19 Jul 2018
Lilly's once-weekly Trulicity (dulaglutide) label updated to include data showing benefits for adults with type 2 diabetes and chronic kidney disease
19 July 2018 - The U.S. label for Eli Lilly's once-weekly Trulicity (dulaglutide) is updated to show the medicine's safety and ...
Posted by Michael Wonder on 18 Jul 2018
Novartis Kisqali now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for pre-menopausal women; and as initial therapy with fulvestrant in postmenopausal women
18 July 2018 - Kisqali is now the only CDK4/6 inhibitor indicated in combination with an aromatase inhibitor as first-line treatment ...
Posted by Michael Wonder on 18 Jul 2018
Janssen announces U.S. FDA approval of Symtuza, the first and only complete darunavir-based single tablet regimen for the treatment of HIV-1 infection
17 July 2018 - Once daily, single-tablet regimen delivers the durability and high barrier to drug resistance of darunavir and the ...
Posted by Michael Wonder on 15 Jul 2018
U.S. FDA approves Xtandi (enzalutamide) for the treatment of men with non-metastatic castration-resistant prostate cancer
13 July 2018 - First and only oral treatment FDA approved for both non-metastatic and metastatic castration-resistant prostate cancer. ...
Posted by Michael Wonder on 13 Jul 2018
FDA approves the first drug with an indication for treatment of smallpox
13 July 2018 - The U.S. FDA today approved Tpoxx (tecovirimat), the first drug with an indication for treatment of smallpox. ...
Posted by Michael Wonder on 11 Jul 2018
Bristol-Myers Squibb’s Opdivo (nivolumab) & low-dose Yervoy (ipilimumab) is the first immuno-oncology combination approved for MSI-H/dMMR mCRC patients who progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan
11 July 2018 - Opdivo & Yervoy is now approved in three tumour types, dosing and administration varies by tumour. ...
Posted by Michael Wonder on 04 Jul 2018
FDA approves Xeomin (incobotulinumtoxina) for adult patients with sialorrhoea
3 July 2018 - First and only neurotoxin approved for this indication in the United States. ...
Posted by Michael Wonder on 02 Jul 2018
FDA approves Aristada Initio for the initiation of Aristada for schizophrenia
2 July 2018 - Novel regimen enables physicians to fully dose up to two months of Aristada treatment on day one. ...
Posted by Michael Wonder on 02 Jul 2018
Dermira receives FDA approval for Qbrexza (glycopyrronium) cloth to treat primary axillary hyperhidrosis
29 June 2018 - Qbrexza is expected to be available for prescribing in October 2018. ...
Posted by Michael Wonder on 02 Jul 2018
Acadia Pharmaceuticals announces FDA approval of new dosing formulation and strength for Nuplazid (pimavanserin)
29 June 2018 - New dosing formulation and strength address needs in treating patients with hallucinations and delusions associated with Parkinson’s ...
Posted by Michael Wonder on 27 Jun 2018
Metastasis-free survival — a new end point in prostate cancer trials
27 June 2018 - Earlier this year, the FDA approved apalutamide, an androgen receptor inhibitor, for treatment of patients with non-metastatic ...
Posted by Michael Wonder on 27 Jun 2018
Array BioPharma announces FDA approval of Braftovi (encorafenib) in combination with Mektovi (binimetinib)
27 June 2018 - Approval based on Phase 3 COLUMBUS trial which demonstrated nearly 15 months median progression-free survival. ...
Posted by Michael Wonder on 27 Jun 2018
Zemdri (plazomicin) approved by FDA for the treatment of adults with complicated urinary tract infections
26 June 2018 - Zemdri is a new treatment for patients with cUTI, including pyelonephritis, due to certain Enterobacteriaceae. ...