The regulator noted in its early 2014 retrospective that it set a high mark for the number of approved rare disease drugs this year, and that insufficient information is the reason many breakthrough status requests get bounced.
The Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.
CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.
As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.
Ackman walks away with $2.5 billion, despite no Allergan deal; Ranbaxy sues FDA over generic Nexium rights; Indian government's Health Ministry recommends breaking BMS cancer drug patent.
A US Senate bill would also make treatments for the disease eligible for priority review vouchers.
The new language is in response to a 2011 citizen's petition.
Amgen sues Sanofi and Regeneron over PCSK9 patents; FDA panel wants Chantix black box to stay; Valeant-Allergan uproar rises in pitch; Pharmacyclics and Roche team up against CLL; and GSK's Ebola vax may "miss" the current crisis.
Pre-review documents indicate a favorable opinion of the IL-17 inhibitor secukinumab.
Resignations stymied the Office of Pharmaceutical Quality's beginning.
The company is working with the FDA on new clinical trial requirements.
Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep
The FDA's Office of Prescription Drug Promotion says Pacira's promotional materials for Exparel are "extremely concerning," but the drugmaker tells investors the fuss is probably because opioids have been getting a lot of attention lately.
The reason: opioids.
Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.
An FDA advisory panel will consider evidence supporting a weight-loss indication Thursday.
The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).
Bloomberg reports that India's Wockhardt has become an M&A target.
FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.
Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"
The regulator and patients will chat for two days in October.
Cologuard was the first approved fecal-based screening test for the disease, and it was also the first product the FDA and CMS approved on the very same day through the so-called Parallel Review program.
The regulator has already issued more recalls in the first half of 2014 than it has over the past nine years.
The experimental drug is being reviewed for patients with intermediate or high-risk myelofibrosis.
Three House democrats are asking the FDA to get the chemical out of US drugs ASAP.
The FDA issued a Warning Letter over unapproved drug claims published in Spanish.
FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic communications environment.
The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.
The FDA's Center for Drug Evaluation and Research's Office of Communications wants a system that will help assess its messaging reach across the interwebs and its many forums.
It's the second for this cancer drug in two weeks.
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