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Baxter International said it will launch its hemophilia drug Obizur in the next few months, after the FDA approved the product late Thursday. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval following its recent meeting, including products to treat intolerance to sunlight, ovarian cancer, oestrogen deficiency and hemophilia B. Read More
The UK’s cost-effectiveness watchdog has recommended coverage of Bayer’s blood thinner Xarelto for preventing blood clots in people who have had a heart attack based on evidence the drug can decrease the cardiovascular risk by up to 20 percent. Read More
The UK healthcare cost watchdog gave the final green light for national coverage of GlaxoSmithKline’s skin cancer drug Tafinlar, a decision that was made in record time, according to the drug’s evaluators. Read More
Pfizer is the latest company to win approval of opioid abuse-deterrent labeling, after the FDA cautiously okayed new statements about Embeda late Friday. Read More
The UK’s healthcare cost agency affirmed its June recommendation to cover Novartis’ cancer drug Glivec as an adjuvant treatment for patients at high risk of post-surgery recurrence of gastrointestinal stromal tumors. Read More
The European Medicines Agency has approved Janssen and Pharmacyclics’ blood cancer drug Imbruvica for two indications, a move that follows similar approvals in the U.S. this summer. Read More
The FDA’s proposal that drugmakers add microbiology and pharmacogenics information to product labels should apply only to new prescription drugs and biologics, said industry experts. Read More