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The FDA has sent New Jersey-based Bi-Coastal Pharma International a warning letter, insisting that the company complete a complaint investigation rather than passing the buck to its now-defunct supplier. Read More
Avadel Pharmaceuticals has sued the FDA and HHS for holding up review and approval of its Lumryz narcolepsy drug after making administrative errors in the approval process, including delaying the review 10 months beyond the legal limit and requiring an unneeded patent certification. Read More
Sandoz’s biosimilar of Biogen’s blockbuster multiple sclerosis drug Tysabri (natalizumab) has gained new regulatory footholds with both the FDA and the European Medicines Agency (EMA). Read More
Teva Pharmaceuticals has agreed to a proposed $4.25 billion settlement to resolve lawsuits brought by more than 2,500 U.S. cities, counties, states and Native American tribes over the company’s alleged role in the opioid crisis. Read More
The defendants are barred from seeking or accepting reimbursement for any Gilead medication dispensed to individuals enrolled in the programs. Read More
Boise, Idaho-based Episciences was issued an 8-observation Form 483 for missing testing procedures, deficient cleaning and other quality lapses. Read More
A three-judge panel has rejected Pfizer’s plan to help Medicare patients pay for one of its most expensive drugs, citing the federal anti-kickback statute. Read More
The FDA has granted priority review status to Biogen’s New Drug Application for tofersen, giving the drugmaker an early win in its battle for an amyotrophic lateral sclerosis (ALS) therapy. Read More
Sens. Cory Booker (D-N.J.) and Rand Paul (R-Ky.) introduced a bill yesterday seeking to update the Right to Try Act to permit terminally ill patients to access Schedule I drugs that have completed a phase 1 trial — including MDMA and psilocybin. Read More