Topic:

Regulatory

Latest Headlines

Latest Headlines

Rollout of openFDA continues with drug labeling, medtech adverse event APIs

Having committed to a fast rollout of APIs at the start of the summer, the FDA made good on its promise this week by making data on drug labeling available. And the regulator went beyond its initial commitment by releasing an API for medical device adverse events.

FDA approves more innovative med tech, faster in first half

The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from 23 for the entirety of 2013.

GlaxoSmithKline's ViiV wins FDA nod for three-in-one HIV treatment

ViiV Healthcare, the HIV-focused venture majority-owned by GlaxoSmithKline, picked up FDA approval for a single pill that combines three antivirals and promises to challenge a leading treatment from Gilead Sciences.

FDA warns Kentucky drug compounder after sick, dead horses reported

The FDA is coming down on drug compounder Wickliffe Pharmaceuticals for poor compliance to manufacturing practices after receiving a report that two horses died following adverse reactions to drugs produced by the Lexington, KY-based operation.

Answer to mystery of Ranbaxy 'settlement discussions' may be found in Texas

Beleaguered Indian drugmaker Ranbaxy Laboratories set aside about $40 million in its last quarter for "ongoing settlement discussions." Now sources are suggesting the drugmaker's need for the funds: a settlement with the state of Texas.

Pfizer, BMS pad bright Q2 with new FDA nod for Eliquis

Pfizer and Bristol-Myers Squibb's Eliquis has been lagging since launch time, trailing behind predecessors Pradaxa and Xarelto. But lately, the drugmakers' efforts have been paying off when it comes to market share, and a new indication may help keep the ball rolling.

UPDATED: FDA clears first smartphone-based device to detect atrial fibrillation

AliveCor announced Aug. 21 that it has received FDA clearance for an algorithm to detect atrial fibrillation, and next month it plans to incorporate the new ability into its AliveECG app for monitoring the heart.

Cubist nears another big antibiotic approval as M&A rumors simmer

Lexington, MA's Cubist Pharmaceuticals is inching toward its second drug approval of the year, hoping to win European and U.S. clearance for a new anti-infective as analysts wonder whether the company is in line for a Big Pharma takeout.

DEA tightens opioid dispensing rules amid controversy over abuse

On Thursday, the Drug Enforcement Agency (DEA) announced that combination drugs containing hydrocodone will now be classified as Schedule II products, imposing on them the same restrictions that apply to pure hydrocodone, as well as oxycodone and morphine.

FDA allows Covidien to restart manufacturing of two recalled devices

The FDA approved Covidien's fixes to the manufacturing process of its recalled Pipeline Embolization Device and Alligator Retrieval Device for treating brain aneurysms.