FDA: Page
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FDA reprimands Gilead for paid-search link
The agency is starting to regulate social media communications more forcefully.
By Nicole Gray • July 10, 2014 -
Newly acquired Forest Labs lays off 190 employees in Missouri
With the Actavis takeover complete, changes are underway.
By Nicole Gray • July 10, 2014 -
FDA to review NDA for Sanofi's new basal insulin
In clinical trials, Toujeo met all of its primary endpoints.
By Nicole Gray • July 9, 2014 -
Norvatis' leukemia therapy gets breakthrough status from FDA
The new immunotherapy technology was co-developed with the University of Pennsylvania.
By Nicole Gray • July 8, 2014 -
Ono's Opdivo becomes first approved anti-PD-1 medication
Several similarly targeted medications remain in various phases of clinical development.
By Nicole Gray • July 8, 2014 -
FDA puts government-funded ebola study on clinical hold
The move almost certainly is short-term while more data is gathered.
By Nicole Gray • July 7, 2014 -
Teva files citizen petition as it defends Copaxone patent
The company continues to assert the need for clinical trial data for approval of a generic version.
By Nicole Gray • July 7, 2014 -
Spectrum does it again, gains approval for another lymphoma drug
PTCL is a fast-moving cancer that kills almost 19,000 people per year.
By Nicole Gray • July 7, 2014 -
EMA to review programmed-death cell drug for cancer treatment
If approved, this drug will be the first PD-1 cancer treatment in Europe.
By Nicole Gray • July 3, 2014 -
France recommends use of off-label Avastin for AMD
Lawmakers are focused on cost savings, but cite evidence-based efficacy and safety as justification.
By Nicole Gray • July 2, 2014 -
Pozen takes aspirin/omeprazole combo back to FDA
The company has addressed concerns over its manufacturing facility.
By Nicole Gray • July 2, 2014 -
MannKind gets major boost after FDA approves inhaled insulin
This approval is a long time coming and could have a major impact on compliance among diabetes patients.
By Nicole Gray • June 30, 2014 -
Janssen files for expanded use of Velcade in EU patients
The company wants to make the drug available for patients with mantle cell lymphoma.
By Nicole Gray • June 30, 2014 -
NICE changes its position on Glivec use
The agency is liberalizing its previous stance even though the drug costs more than $35,000 per year.
By Nicole Gray • June 30, 2014 -
CHMP approves BMS' combo hep C therapy
The treatment is moving forward in Europe.
By Nicole Gray • June 30, 2014 -
Viiv's HIV combo drug recommended for approval by EMA advisers
It's likely the drug will become a formidable competitor to Gilead's Atripla.
By Nicole Gray • June 30, 2014 -
EMA recommends approval of Lilly's Lantus biosimilar
The decision marks a landmark moment for the biosimilars industry.
By Nicole Gray • June 27, 2014 -
EU advisors recommend Avastin for refractory ovarian cancer
The drug will be used in combination with chemotherapy to improve outcomes.
By Nicole Gray • June 27, 2014 -
Generic version of Diovan from India approved by FDA
This is the first generic version of the blood pressure drug available in the U.S.
By Nicole Gray • June 27, 2014 -
Boehringer's Pradaxa reversal drug gets breakthrough therapy status
The ability to reverse anticoagulation could help Pradaxa become the leading anticoagulant.
By Nicole Gray • June 27, 2014 -
Eisai files NDA for lenvatinib in Japan
Thyroid cancer affects up to 29,000 people in Japan.
By Nicole Gray • June 27, 2014 -
Deep Dive
4 takeaways about the U.S. biosimilars market
Take a deeper look at the emerging market, which could trigger a substantial reduction in key healthcare costs.
By Nicole Gray • June 26, 2014 -
NICE recommends Invokana for diabetes
This is the 10th drug that NICE has recommended for treatment of type 2 diabetes.
By Nicole Gray • June 26, 2014 -
FDA
FDA requests additional information on AstraZeneca's ovarian cancer drug
The agency has concerns related to efficacy and safety.
By Nicole Gray • June 26, 2014 -
High-dose liraglutide may be the next weight-loss breakthrough
It decreases risk of progression to diabetes in individuals with pre-diabetes.
By Nicole Gray • June 26, 2014
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