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Merck has found a way forward for its stalled oral antiretroviral islatravir, using a lower, 0.75 mg dose in three newly launched phase 3 trials and in a previously paused phase 2 trial that has been languishing under a clinical hold after patients developed decreases in total lymphocyte and CD4+ T-cells. Read More
At least 88 additional lawsuits have been filed in Delaware against GSK and former Zantac (ranitidine) owners Pfizer, Boehringer Ingelheim and Sanofi, alleging the heartburn drug increases users’ risk of cancer. Read More
In addition to being interchangeable with their reference products, biosimilars approved in the EU are interchangeable with an equivalent biosimilar, the European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) said in a joint statement. Read More
Resolving allegations that it violated the False Claims Act, generic drugmaker Akorn has entered into a settlement to pay $7.9 million for causing Medicare to be billed for three over-the-counter (OTC) drugs that were no longer eligible for Medicare coverage. Read More
Vanda Pharmaceuticals is suing the FDA for the third time in 2022 — this time over what the company claims is FDA’s “unlawful” delay in granting a public hearing to Vanda regarding expanding the approval of the company’s sleep disorder drug Hetlioz (tasimelteon) to also include the treatment of jet lag disorder. Read More
After a series of rejections, the FDA has finally approved Mallinckrodt’s Terlivaz (terlipressin) for treating adults suffering from hepatorenal syndrome (HRS), a life-threatening condition involving rapid reduction in kidney function. Read More
Bluebird Bio’s gene therapy Skysona (elivaldogene autotemcel) has snagged accelerated approval as a treatment for early, active cerebral adrenoleukodystrophy (CALD), an invariably fatal genetic disorder that strikes young boys. Read More