Federal judge strikes down FDA limits on abortion pill

A U.S. federal judge in Maryland ruled that the FDA's restrictions on the abortion medication mifepristone were unlawful, benefiting plaintiffs from three states. The decision blocks requirements for in-person dispensing and a reduced gestational age limit. This preserves broader access to the drug used in most medication abortions.

Federal judge blocks expanded access to abortion pill mifepristone

October 03, 2025 Ti AI ṣe iroyin

A federal judge in Texas has issued a ruling limiting the FDA's approval of mifepristone, the primary drug used in medication abortions. The decision revives a long-standing lawsuit challenging the drug's safety and regulatory process. This comes amid ongoing legal battles over abortion access following the Supreme Court's overturning of Roe v. Wade.

Coalition Opposes FDA's Proposed Ban on 7-OH Substance

A diverse group of organizations has publicly criticized the U.S. Food and Drug Administration's proposed ban on 7-Hydroxymitragynine (7-OH), arguing it threatens public health and ignores scientific evidence. The coalition, including health advocates and industry representatives, issued a joint statement on September 23, 2025, urging the FDA to reconsider. They claim the ban could limit access to potential therapeutic alternatives amid the ongoing opioid crisis.

FDA Approves New Schizophrenia Treatment

The US FDA has approved a new treatment for schizophrenia that promises fewer side effects than existing options. This marks a significant step forward in mental health medication.

FDA issues final rule on clinical trials diversity

September 30, 2025 Ti AI ṣe iroyin

The U.S. Food and Drug Administration has finalized a rule requiring drug sponsors to submit diversity action plans for clinical trials. This aims to ensure better representation of underrepresented groups in medical research. The rule takes effect in 2025.

FDA Grants Accelerated Approval for First Barth Syndrome Treatment

The U.S. Food and Drug Administration has granted accelerated approval to Forzinity, the first treatment for Barth syndrome, a rare X-linked genetic disorder primarily affecting males. Developed by Stealth Biotherapeutics, the therapy targets mitochondrial dysfunction underlying the condition, offering new hope for patients with this life-threatening disease. This milestone follows years of advocacy and highlights progress in addressing ultra-rare disorders.

FDA Approves Drug for Autoimmune Neuropathies

The FDA approved a new drug for treating autoimmune neuropathies on September 9, 2025, accompanied by discoveries of new autoantibodies and effective complement inhibitors. This development ends 30 years of limited treatment progress in the field.