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FDA

Latest Headlines

Latest Headlines

Gunning for a spot in the next-gen autoimmune market, Lilly med hits goals in latest trial

Eli Lilly's closely watched autoimmune treatment ixekizumab met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.

FDA approves new device for surgical sealing during cranial procedures

The FDA approved HyperBranch Medical Technology's Adherus AutoSpray Dural Sealant to provide watertight closure during cranial procedures, according to a March 30 approval letter. Approval came via the stringent PMA pathway, which included a clinical trial, after which Adherus was deemed noninferior to Integra LifeSciences' surgical sealant system.

Otsuka scrambles to persuade judge to block Abilify copycats

Otsuka has already sued the FDA to block generic versions of the blockbuster antipsychotic Abilify, claiming that its orphan drug exclusivity on one indication should preclude copycat meds entirely.

FDA stepping up efforts to replenish U.S. saline solution supplies

The FDA said it's stepping up its efforts to address the shortage of saline solution for humans and animals by increasing the importation of intravenous fluids from producers not previously approved by the regulatory agency.

J&J's Invokana fends off new SGLT2 rivals to hit $278M in Q1

Johnson & Johnson's SGLT2 inhibitor Invokana (canagliflozin)--among a handful of drugs in the new category of DPP-4 drugs for diabetes--not only took a big jump in sales for the first quarter but also made some significant market-share gains.

Takeda, AstraZeneca diabetes drugs need warnings on heart risk, FDA says

Diabetes drugs of Takeda Pharmaceutical and AstraZeneca should be labeled at risk of heart failure associated with them, a group of U.S. FDA advisers recommended. Nearly all of the members of an advisory panel voted for the added safety information on labels.

Smoke and mirrors on visas to increase U.S. FDA inspectors in China, WSJ says

Remember all the post-heparin-scare hoopla about the U.S. FDA increasing the number of inspectors on the ground in China to 26? Seven years later, it still has only three drug inspectors working full time and two temporarily, the total down from 8 last year, the Wall Street Journal reports.

IDT Australia release on FDA nod for 23 generics begs the question: Where's the beef?

Australia Stock Exchange-listed IDT Australia has issued another in a series of announcements about acquiring 23 generic drugs marketed in the United States, the latest release stating the U.S. FDA has noted the transfer of ownership to IDT.

FDA clears patient monitoring device focused on IVs

ivWatch announced the FDA's clearance of its namesake product to continuously monitor peripheral IVs for adverse events like infiltration of IV fluids into the surrounding skin and the leakage of medications from the tubes.

FDA announces LuSys Labs' recall of its unapproved Ebola diagnostic

The FDA cracked down on San Diego's LuSys Laboratories for selling an unapproved diagnostic for Ebola. It announced that the company recalled all 2,000+ units of its Ebola Virus One Step Test Kits in March and destroyed any remaining kits. It deemed the recall Class I, meaning exposure to the violative "product will cause serious adverse health consequences or death."