As a U.S. appeals court ruling that restores the original restrictions the FDA imposed on the abortion drug mifepristone in 2000 heads to the Supreme Court for what will likely be full argument, the Biden administration continues to insist that the courts have no business overriding the FDA’s “scientific, evidence-based decisions.” Commenting on the Aug. 16 opinion from the U.S. Court of Appeals for the Fifth Circuit, which reinstated the original use restrictions, Vice President Kamala Harris said, “It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA.”

China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China. The approval is for treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia (abnormal lipid levels). Tafolecimab marks Innovent's first cardiovascular drug as well as the company’s 10th approval.

There are plenty of companies chasing the first U.S. FDA-approved treatment for the ultra-rare disease fibrodysplasia ossificans progressiva (FOP), but Ipsen SA stayed the course longer and won that approval Aug. 16 with Sohonos (palovarotene). Other companies have struggled to develop a treatment for FOP, which affects about 400 people in the U.S. and about 900 people worldwide. Some potential competitors are still in the clinic, trying to catch up.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Artiva, Biophytis, Bluebird, Servier, Sonnet, US Worldmeds.

The U.S. FDA has given its first approval for treating fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease that creates bone formation outside the skeleton that can lead to immobility, life-threatening respiratory problems and a total locking of the jaw.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Arcellx, Avidity, Biocorrx, Biostax, Immpact, Oncusp, Pfizer, Thryv, Tiziana, Venatorx, Wugen.

It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.

Often when the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) determines that the marketing of a drug crosses the line of misbranding, it hands the sponsor an untitled letter schooling it on how the promotional materials run afoul on safety or efficacy claims.