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In the ongoing battle of pro-life groups vs. the government on access to the so-called abortion pill, the FDA is pressing a Texas judge to reject a request by anti-abortion groups for a court order withdrawing federal approval for the drug. Read More
AbbVie and Eli Lilly have pulled out of a voluntary UK drug pricing agreement for the National Health Service (NHS) — a move that could leave NHS patients with curtailed access to their therapies. Read More
Last year’s decision by HHS to limit payment for Biogen’s controversial Alzheimer’s drug Aduhelm to patients in a clinical trial could have a long-term negative effect on the entire accelerated approval (AA) pathway, said former FDA Commissioner Scott Gottlieb. Read More
Oncology drug trials should consider a wide range of dosages and how they impact a wide variety of participants, rather than immediately titrating patients up to the maximum tolerated dose (MTD), the FDA said in a new draft guidance. Read More
Astellas Pharma has filed a federal lawsuit accusing China’s Qilu Pharma of infringing on its patent protections for the blockbuster overactive bladder drug Myrbetriq (mirabegron) by preparing a generic version. Read More
Rybelsus had been indicated only as an adjunct treatment, along with diet and exercise, to improve glycemic control in adults with type 2 diabetes. Read More
Reforms in orphan drug exclusivity will see significant movement in 2023, according to Andi Fristedt, the FDA’s deputy commissioner for policy, legislation, and international affairs. Read More