FDA

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The FDA has issued draft guidance that funds FDA inspection of some drug compounders.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

Xolair indicated for hives

The FDA's approval makes Genentech's drug the first biologic for chronic hives.

FDA approves oral psoriatic arthritis drug

FDA approves oral psoriatic arthritis drug

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Celgene is looking to market the $22,500-a-year-drug as a pre-biologic, which means jumping ahead of rivals like Enbrel and Humira.

EMA advisory panel backs Lilly/BI's empagliflozin

EMA advisory panel backs Lilly/BI's empagliflozin

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The Committee for Medicinal Products for Human Use endorses the SGLT2 inhibitor. The FDA refused to approve the drug earlier this month because of manufacturing issues.

FDA wants parents to back off fetus selfies

The regulator says at-home ultrasounds and heart monitoring systems are a bad idea.

Regulators, unite! Hamburg urges global cooperation

Plans for a "new regulatory supergroup" are reported to have been in the works for some time.

OPDP slams Facebook page

OPDP slams Facebook page

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The FDA's bad-ad unit took a drugmaker to task for what it calls a misleading Facebook page. History shows the social media surveillance should take no one by surprise.

DOJ may cost Aegerion patients

The drugmaker's annual report indicates the company is concerned that an investigation into its marketing could dissuade doctors from prescribing Juxtapid.

Proposed budget gets mixed reviews

The White House's proposed FY 2015 budget gives an additional 1% to the FDA.

New FDA Twitter feed has diverse following

@openFDA and its related website launched February 27.

FDA slammed over generics

Critics say the FDA is not doing enough to ensure generics quality and that communications between industry and the regulator need to improve.

Daclatasvir combo gets Breakthrough status

The FDA granted Breakthrough status to the daclatasvir + asunaprevir combo for hepatitis C patients with genotype 1b.

FDA seeks flexible OTC review process

The agency says is it time to update the onerous decades-old review process.

FDA launched stealth drug testing op

The regulator kicked off a $20-million generics testing project in September.

FDA's Hamburg says India is a significant pharma partner

FDA's Hamburg says India is a significant pharma partner

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The FDA commissioner said the agency is doing its job, not picking a fight, when it inspects drug-making facilities, and that India must take an active role for a harmonious supply chain.

FDA may ditch some TV ad requirements

A consumer survey will shape the regulator's position.

Medisca recalls swapped drugs

The FDA found that drugs marked L-citrulline contained drugs that treat vertigo, instead of the components that treat a rare genetic disorder.

Xarelto indication stays as-is

The FDA rejected J&J's expanded indication request a third time.

J&J cancer med adds indication, lower dose

J&J cancer med adds indication, lower dose

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The fast-tracked drug netted another indication today, this one for a form of leukemia. Lower dosage of the drug for that indication shrinks the price compared to lymphoma.

Panel says NSAID labels should not change

An advisory panel voted 16-9 against a label change that could give naproxen a heart-friendlier label than other NSAIDs.

FDA takes closer look at AZ's saxagliptin

FDA takes closer look at AZ's saxagliptin

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The regulator says a 2013 study that indicated a higher rate of heart failure compared to placebo—but not death—has prompted a second look at the diabetes medication.

FDA overhaul coming

The agency is reorganizing and encouraging specialization.

Must biosimilar names be distinct? No, experts argue

Must biosimilar names be distinct? No, experts argue

Innovator companies want the FDA to adopt separate names for biosimilars. Manufacturing changes aren't drastic enough to make it necessary, experts argued at an FTC workshop.

FDA panel to review NSAIDs this month

A panel is meeting February 10 to discuss revoking the OTC status of some medications.

Pfizer releases Ph. II palbociclib data

Pfizer releases Ph. II palbociclib data

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The company said in a statement that it is talking with the FDA about next steps. Data on overall survival—a key metric for how oncologists view new cancer meds—remains under wraps.

Testosterone drugs under FDA review

Testosterone drugs under FDA review

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Studies associating the therapies with higher heart risks triggered the review.

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