Blog
RSS FeedPosted by Michael Wonder on 04 Jan 2018
Landmark schizophrenia data that bring hope in breaking the cycle of hospitalisation and incarceration receive FDA approval for inclusion in Invega Sustenna (paliperidone palmitate) label
3 January 2017 - Invega Sustenna is the first and only antipsychotic to demonstrate superior effectiveness in delaying time to ...
Posted by Michael Wonder on 29 Dec 2017
New drug approvals for FDA: 2017 hits 21 year high
21 December 2017 - The number of new molecular entities approved by the US FDA in 2017 (46 so far, ...
Posted by Michael Wonder on 28 Dec 2017
Horizon Pharma announces FDA approval to expand the indication for Procysbi (cysteamine bitartrate) delayed-release capsules to include children one year of age and older living with nephropathic cystinosis
27 December 2017 - Horizon Pharma today announced the U.S. FDA has approved an expansion to the indication for Procysbi (cysteamine ...
Posted by Michael Wonder on 26 Dec 2017
Six health stories to watch in 2018
24 December 2017 - A new year could bring new treatments for migraines and breast cancer, greater access to a powerful ...
Posted by Michael Wonder on 23 Dec 2017
Many FDA approved cancer drugs might lack clinical benefit
21 December 2017 - New research shows that less than half of the randomised controlled trials that support the approval of ...
Posted by Michael Wonder on 23 Dec 2017
Agile Therapeutics receives a complete response letter from the FDA for Twirla (AG200-15) for the prevention of pregnancy
22 December 2017 - Agile Therapeutics today announced that the U.S. FDA issued a complete response letter in response to ...
Posted by Michael Wonder on 23 Dec 2017
Santen receives complete response letter from U.S. FDA for intravitreal sirolimus (DE-109)
21 December 2017 - Santen Pharmaceutical today announced that the U.S. FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 22 Dec 2017
FDA updates the label of Tasigna to reflect that certain patients with a type of leukaemia may be eligible to stop treatment after sustained response
22 December 2017 - Discontinuation in treatment marks a first in chronic myeloid leukaemia. ...
Posted by Michael Wonder on 22 Dec 2017
FDA approves drug to treat dangerously low blood pressure
21 December 2017 - The U.S. FDA today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in ...
Posted by Michael Wonder on 21 Dec 2017
Diabetes is officially the messiest drug market
22 December 2017 - A crowded space gets more so as the FDA approves Pfizer/Merck's Steglujan. ...
Posted by Michael Wonder on 21 Dec 2017
FDA approves Genentech’s Perjeta (pertuzumab) for adjuvant treatment of specific type of early breast cancer
20 December 2017 - Accelerated approval of Perjeta for neo-adjuvant use also converted to full approval. ...
Posted by Michael Wonder on 21 Dec 2017
Aeterna Zentaris announces FDA approval of Macrilen (macimorelin) for diagnosis of adult growth hormone deficiency
20 December 2017 - Aeterna Zentaris announced today that the U.S. FDA has granted marketing approval for Macrilen (macimorelin), an orally ...
Posted by Michael Wonder on 21 Dec 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) as adjuvant therapy in patients with completely resected melanoma with lymph node involvement or metastatic disease
20 December 2017 - Opdivo, the first and only anti-PD-1 immune checkpoint inhibitor approved for adjuvant treatment of melanoma, is indicated ...
Posted by Michael Wonder on 20 Dec 2017
U.S. Food and Drug Administration approves prior approval supplement for commercial launch of Portola Pharmaceuticals’ novel oral anti-coagulant Bevyxxa (betrixaban)
19 December 2017 - Bevyxxa available to patients in January 2018. ...
Posted by Michael Wonder on 20 Dec 2017
Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) tablets for previously untreated advanced renal cell carcinoma
19 February 2017 - Approval expands indication and comes well in advance of PDUFA date of 15 February 2018. ...