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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
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
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
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 new medicines for EU marketing authorizations at its July 18-21 meeting. Read More
Several cancer organizations have voiced strong support for the Biden administration’s apparent pick for National Cancer Institute (NCI) director, Monica Bertagnolli, a distinguished surgical oncologist with a long career in clinical research. Read More
The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a call to bring stakeholders together in a discussion about using real-world evidence (RWE) and real-world data (RWD) in bringing new medicines to market. Read More