France's drug regulators last year faced scathing criticism for dragging their feet when it came to the dangers of off-label use of diabetes drug Mediator. Now faced with consumer fears over deaths tied to off-label use of Bayer acne drug, Diane-35, they are acting with dispatch.
The big news in generic drugs in the last couple of years has been all of the marquee brands that are getting their tails kicked by generic competition. The best example is the loss of the patent on...
Janssen Pharmaceuticals has again temporarily wrestled to the ground another potential generics competitor to its Ortho Tri-Cyclen Lo contraceptive.
Bayer, already one of the biggest players in the $8 billion a year contraceptive drug market, is aiming to take on Johnson & Johnson ($JNJ) in Europe with a transparent birth control patch.
Novartis' generic unit Sandoz is recalling 10 lots of a birth-control pill, Introvale, after finding the pills packaged in the wrong sequence. It's the third time this year that drugmakers have recalled mispackaged contraceptive pills.
A new study says girls under 17 can safely use Plan B without a prescription.
Pill mix-ups and potency questions have prompted dozens of recalls in recent months. This time, the potential for both has Pfizer ($PFE) pulling 1 million packages of contraceptive pills. The balance...
The first Yaz trial won't open as scheduled. A federal judge delayed the bellwether patient lawsuit, set for trial next week, and appointed a special master to mediate instead. And this special
After a week of arguments and protests, the FDA has denied a citizen's petition from the Center for Reproductive Rights on allowing greater access to generic versions of the Plan B contraceptive for
An FDA advisory committee backed Bayer's ($BAY) birth control pills Yaz and Yasmin in a 15-11 vote yesterday, saying their benefits outweigh their risks. But the panel also recommended changes to the