FDA

Imbruvica lassoes CLL indication

The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.

FDA asks social media "how'm I doin?"

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.

Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

FDA generic division overhaul kicks in

The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.

Vet drugmakers get Warning Letters too

Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.

"Likes" put Zarbee's in FDA crosshairs

"Likes" put Zarbee's in FDA crosshairs

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The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.

BI drug gets priority review

Boehringer Ingelheim's experimental idiopathic pulmonary fibrosis treatment nintedanib is also an orphan drug.

Researchers give FDA social media advice

Researchers give FDA social media advice

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Researchers from Boston Children's Hospital, Harvard Medical School and Brigham and Women's Hospital are offering a bit of internet advice for the Food and Drug Administration: do more.

FDA wants male breast cancer patients

The regulator wants men to be part of breast cancer clinical trials.

Vertex to submit CF drug combo to FDA this year

Vertex to submit CF drug combo to FDA this year

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Phase III results showing improved lung function among cystic fibrosis patients using a combination of Kalydeco and lumacaftor means drugmaker Vertex is filing the two-part drug for FDA approval during the fourth quarter.

PhRMA uneasy about "right-to-try" laws

Colorado's version of the FDA's compassionate use rule does not sit well with lobbying group Pharmaceutical Research and Manufacturers of America.

Lilly, BI resubmit diabetes medication

The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.

HealthKit won't tangle with the FDA

Recent FDA guidelines for health-tracking apps mean Apple's HealthKit, and similar apps, won't have to jump regulatory hurdles before going live.

Campaigners want FDA to focus on women's sexual health

Campaigners want FDA to focus on women's sexual health

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A coalition of organizations, including pharmaceutical company Sprout, kicked off a campaign urging the FDA to pay as much attention to women's sexual dysfunction needs as it does to men's.

FDA examines DTC close up

FDA examines DTC close up

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The regulator's latest study will use eye-tracking tools.

FDA invests in clinical trial data

The regulator is allocating almost $38 million to improve data-guided decision-making.

Sun's FDA Warning Letter

Sun's FDA Warning Letter

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The FDA's seven-page letter outlines some of the problems the regulator has with one specific Sun site.

FDA seeks math of similarity

A three-year, $1 million project seeks an equation for generics and biosimilars.

FDA says no to Novartis heart drug

FDA says no to Novartis heart drug

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Novartis says the FDA wants more serelaxin efficacy data.

BMS, AbbVie land Breakthrough label

The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.

FDA standing by its Zohydro approval

FDA standing by its Zohydro approval

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The regulator defends its approval decision in a web post.

FDA has another look at Chantix

The review includes data the regulator requested about the smoking-cessation drug.

FDA reviews new painkiller

The candidate would be the first to put oxycodone and morphine in one capsule.

Sarepta plans for 2015 drug review

Sarepta plans for 2015 drug review

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The company said it plans to file its rare-disease drug with the FDA later this year, for a 2015 review.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

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The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

GSK accused of wrongdoing in Poland, Wellbutrin generic revoked

Poland joins the list of countries in which GlaxoSmithKline is accused of misconduct. Meanwhile, bioequivalence issues have prompted the FDA to revoke its approval of GSK's Wellbutrin generic.

Halozyme pancreatic drug study on FDA hold

Halozyme pancreatic drug study on FDA hold

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The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.

Compounders get version of PDUFA

The FDA has issued draft guidance that funds FDA inspection of some drug compounders.

In DC, parties argue generic label freedom

In DC, parties argue generic label freedom

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At a hearing today, Public Citizen and the generics industry are sounding off on an FDA proposal that would allow generics firms to update labels, regardless of whether the brand has or hasn't.

FDA says generics study is wrong

The regulator disputes findings that generic heart drugs made abroad were contaminated.

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