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Boehringer Ingelheim posted positive trial results for another Humira biosimilar, just a month after the FDA approved Amgen’s version, Amjevita. Read More
A year after the first approval of a treatment for female sexual desire disorders, the FDA has released draft guidance for drugmakers looking to develop the next female Viagra. Read More
The FDA and HHS have not responded to a senator’s demand to clarify their enforcement stance on state right-to-try laws that expand terminal patients’ access to unapproved drug therapies, more than 30 days after a hearing on the issue. Read More
Generic drug makers would like a single point of contact for all four offices involved in inspections, an industry official told the GPhA Fall Technical Conference. Read More
Wrong telephone numbers, unsecure email addresses and inconsistent sponsor names are among the common mistakes the FDA sees in regulatory submissions for generics that can trigger delays in the review process. Read More