FDA Approval Articles

Drug Store News

Breast cancer, hepatitis C drugs get FDA approval
Drug Store News
Gilead's Vosevi, which received priority review and breakthrough therapy designations from the FDA, is the latest in its line of single-tablet drug regimens. It combines already approved drugs sofosbuvir and velpatasvir with the new drug voxilaprevir ...
FDA approves Vosevi for Hepatitis CFDA.gov
Gilead Secures FDA Approval For Chronic Hepatitis C Re-Treatment24/7 Wall St.
FDA approves Gilead's drug for chronic hep C patientsReuters
PerfScience -P&T Community -AJMC.com Managed Markets Network -MPR
all 59 news articles »

07/20/2017 07:57 PM


Merck Wins Tentative FDA Approval for Lusduna
Genetic Engineering & Biotechnology News
Merck & Co. said today that it has won tentative FDA approval for its follow-on biologic basal insulin Lusduna™ Nexvue™ (insulin glargine injection). The approval is tentative because Sanofi has sued Merck, contending that Lusduna infringes on ...
Merck:FDA Grants Tentative Approval For LUSDUNA Nexvue, Biologic Basal InsulinMarkets Insider
FDA tentatively approves Merck's copycat of Sanofi's LantusNasdaq
Despite scoring an FDA nod, Merck's biosim Lusduna must wait to challenge LantusFiercePharma
Healio -MedPage Today
all 8 news articles »

07/20/2017 03:57 PM

Hanford Sentinel

'Astounding' second-chance cancer drug heading for FDA approval
Hanford Sentinel
A new gene therapy drug, the first in its class, was recommended for approval to the US Food and Drug Administration by an advisory committee on Wednesday. If approved by the FDA, the agency would consider it the first gene therapy to hit the market.

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07/20/2017 11:16 AM

FDA's Flashing Green Light Boosts Novel Drug Approvals
Seeking Alpha
This week's approvals for Puma (NYSE:PBYI) and Gilead (NASDAQ:GILD) mean that the US FDA has given the green light to more novel drugs this year than across the whole of 2016. Fears of a regulatory slowdown, which arose in the wake of last year's ...

07/19/2017 07:09 PM

Seeking Alpha

Puma Wins FDA Approval: New Hope For HER2-Positive Breast Cancer Patients
Seeking Alpha
In after-hours trade on Monday, Puma Biotechnology (PBYI) announced that the FDA had approved its breast cancer drug neratinib. The drug will be marketed as Nerlynx. Nerlynx is approved to treat the recurrence of breast cancer after other therapies ...
Puma's (PBYI) Breast Cancer Drug Neratinib Gets FDA ApprovalNasdaq
Puma Biotech (PBYI) Scores Breast Cancer FDA ApprovalEconomic Calendar
Puma's Nerlynx unleashed to fight HER2+ breast cancer with 'best case' labelFiercePharma
24/7 Wall St. -CNA Finance (press release) -Motley Fool
all 145 news articles »

07/19/2017 03:35 PM

Puma jumps after FDA approval of breast-cancer treatment
Puma shares moved as high as $96 in late trading after closing at $86.10, though prices settled at closer to $92 later in the after-hours session. The stock enjoyed a larger surge after an FDA panel recommended its approval in May, and has gained more ...

07/18/2017 12:17 AM