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Home » Topics » Regulatory

Regulatory
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FDA approves single-dose Krintafel for radical cure of P. vivax malaria

July 23, 2018

FDA grants approval to Tibsovo for relapsed/refractory AML with IDH1 mutation

July 23, 2018

FDA approves Xtandi for nonmetastatic castration-resistant prostate cancer

July 16, 2018

FDA approves first drug to treat smallpox

July 16, 2018

Doc fee draft boosts telemedicine, but hits new oncology drugs

July 16, 2018
By Mark McCarty
The draft Medicare physician fee schedule (MPFS) is always an event for makers of drugs and devices, and this year is no exception. This time, the draft proposes non-controversially to formalize the specialty practice of heart failure and transplant cardiology, a move that was anticipated. While telehealth would enjoy a renewal of momentum under the terms of the draft, novel oncology drugs would be reimbursed at the wholesale acquisition cost plus 1.35 percent, a considerable shave from the current standard of WAC+6.
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Tegsedi approved in the E.U. for the treatment of hATTR

July 12, 2018

Tegoprazan approved for the treatment of GERD in Korea

July 9, 2018

Trerief approved in Japan for additional indication

July 4, 2018

FDA approves Braftovi + Mektovi for unresectable or metastatic melanoma

June 28, 2018

FDA approves Zemdri for cUTI, but issues CRL for bloodstream infections

June 27, 2018
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