Federal judge blocks expanded access to abortion pill mifepristone

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.

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.

Senator Hawley criticizes FDA approval of new abortion drug

October 03, 2025 Reported by AI

Republican Senator Josh Hawley from Missouri has sharply criticized the Food and Drug Administration for approving a new abortion drug, raising concerns about women's safety and the agency's trustworthiness. In a letter to FDA Commissioner Robert Califf, Hawley accused the agency of prioritizing politics over science. The move highlights ongoing debates over abortion access and regulatory oversight.

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.

Supreme Court upholds FDA approval of mifepristone

September 30, 2025 Reported by AI

The U.S. Supreme Court unanimously ruled on June 13, 2024, that the FDA's approval of the abortion pill mifepristone is valid and remains in effect. The decision dismissed challenges from anti-abortion groups, affirming the agency's regulatory authority. This ruling ensures continued access to medication abortion, which accounts for more than half of U.S. abortions.

FDA Approves Injectable Form of Merck's Keytruda

The U.S. Food and Drug Administration has granted approval for an injectable version of Merck's blockbuster cancer drug Keytruda, marking a significant advancement in treatment options for patients with certain types of cancer. This subcutaneous formulation promises greater convenience over the traditional intravenous method, potentially improving patient adherence and reducing healthcare burdens. The decision, announced on September 19, 2025, underscores ongoing innovations in oncology amid rising demands for more accessible therapies.

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.