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.
The FDA issued an official halt, five days after Halozyme stopped the Phase-II trial because of patient stroke information.
The FDA has issued draft guidance that funds FDA inspection of some drug compounders.
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.
The regulator disputes findings that generic heart drugs made abroad were contaminated.
The FDA's approval makes Genentech's drug the first biologic for chronic hives.
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.
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.
The regulator says at-home ultrasounds and heart monitoring systems are a bad idea.
Plans for a "new regulatory supergroup" are reported to have been in the works for some time.
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.
The drugmaker's annual report indicates the company is concerned that an investigation into its marketing could dissuade doctors from prescribing Juxtapid.
The White House's proposed FY 2015 budget gives an additional 1% to the FDA.
@openFDA and its related website launched February 27.
Critics say the FDA is not doing enough to ensure generics quality and that communications between industry and the regulator need to improve.
The FDA granted Breakthrough status to the daclatasvir + asunaprevir combo for hepatitis C patients with genotype 1b.
The agency says is it time to update the onerous decades-old review process.
The regulator kicked off a $20-million generics testing project in September.
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.
A consumer survey will shape the regulator's position.
The FDA found that drugs marked L-citrulline contained drugs that treat vertigo, instead of the components that treat a rare genetic disorder.
The FDA rejected J&J's expanded indication request a third time.
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.
An advisory panel voted 16-9 against a label change that could give naproxen a heart-friendlier label than other NSAIDs.
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.
The agency is reorganizing and encouraging specialization.
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.
A panel is meeting February 10 to discuss revoking the OTC status of some medications.
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.
Studies associating the therapies with higher heart risks triggered the review.