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The FDA has granted breakthrough therapy designation to AbbVie’s venetoclax to treat relapsed or refractory chronic lymphocytic leukemia in people with a certain genetic abnormality — paving the way for its speedy development and review. Read More
Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, regulators says. Read More
Sponsors of INDs, NDAs, ANDAs and supplemental applications for drugs that are highly soluble in water but not easily absorbed through the intestines can now request waivers of studies proving the drug has a systemic effect or is equivalent to a reference product. Read More
The FDA is not requiring ordinary proof of effectiveness as it strives to approve orphan drugs for some 7,000 diseases, only 300 of which currently have treatment options, a new study concludes. Read More
The FDA has granted British drug giant GlaxoSmithKline an asthma indication for another drug meant to be used with its Ellipta dry powder inhaler. Read More
Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, Health Canada says. Read More