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RSS FeedPosted 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. ...
Posted by Michael Wonder on 20 Dec 2017
U.S. FDA approves Pfizer’s Bosulif (bosutinib) for the treatment of patients with newly-diagnosed PH+ chronic myelogenous leukaemia (CML)
19 December 2017 - Pfizer's third U.S. haematology approval in five months. ...
Posted by Michael Wonder on 19 Dec 2017
FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss
19 December 2017 - Luxturna is the first gene therapy approved in the U.S. to target a disease caused by mutations ...
Posted by Michael Wonder on 19 Dec 2017
Aerie Pharmaceuticals announces U.S. FDA approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
18 December 2017 - Product approved ahead of the Scheduled PDUFA date of 28 February 2018. ...
Posted by Michael Wonder on 15 Dec 2017
Pfizer announces FDA approval of Xeljanz (tofacitinib) and Xeljanz XR for the treatment of active psoriatic arthritis
14 December 2017 - Xeljanz/Xeljanz XR, the first oral JAK inhibitor in the U.S.for adults with moderate to severe rheumatoid arthritis, ...
Posted by Michael Wonder on 14 Dec 2017
FDA approves new Pfizer biosimilar
13 December 2017 - Pfizer-developed biosimilar medicine Ixifi (infliximab-qbtx) receives FDA approval for all eligible indications. ...