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Posts tagged as “FDA”

FDA Authorizes Second Dose of Updated Covid Booster for Older Adults and Immunocompromised Individuals

The FDA has authorized a second dose of the updated Covid booster for older adults and people with weakened immune systems, which is designed to protect against the BA.4 and BA.5 variants of Omicron. This new bivalent formula will replace the multi-dose primary series for those who have not yet been vaccinated, and can be administered as early as four months after the first shot. It is hoped that this will help to reduce the spread of the virus and protect those who are most vulnerable.

Supreme Court Temporarily Blocks Ruling to Pause FDA Approval of Mifepristone, Preserving Nationwide Access

The Supreme Court has temporarily blocked a ruling from a federal judge in Texas that would have put a pause on the Food and Drug Administration's approval of mifepristone, a medicine used in two-step medication abortions. This decision will allow for nationwide access to mifepristone to be preserved until Wednesday, when the justices will consider next steps. Abortion clinics are readying contingency plans in case mifepristone's FDA approval is overturned.

Supreme Court Temporarily Stays Lower Court Ruling on Abortion Pill Mifepristone, Preserving Access for Now

The Supreme Court has issued a temporary stay on a lower court ruling in a dispute involving the Food and Drug Administration's approval of the abortion pill mifepristone. The order requires both sides to weigh in by Tuesday and preserves access to the drug for now. The court will take time to more fully consider the issues raised in the court challenge before making a final decision, though it is unclear when they will make a final ruling.

Biden Administration Asks Supreme Court to Intervene in Emergency Dispute Over Texas Judge’s Ruling on Medication Abortion Drug

The Biden administration has asked the Supreme Court to intervene in an emergency dispute over a Texas judge's ruling which prevents pregnant women from obtaining the key abortion drug mifepristone by mail. The Justice Department argues that the ruling countermands the FDA's scientific judgment and would make it more difficult for women to access the drug, particularly in rural areas. The Supreme Court has yet to respond to the motion, which if accepted, would put the lower court ruling on hold and allow women to continue to access the drug by mail.

Justice Department to Appeal to Supreme Court After Fifth Circuit Court Reimposes Restrictions on Abortion Pill Mifepristone

The Justice Department has announced plans to appeal to the Supreme Court after the Fifth Circuit Court of Appeals reimposed restrictions on mifepristone, commonly known as the abortion pill. Attorney General Merrick Garland said the Justice Department "strongly disagrees" with the court's decision and will be asking the Supreme Court to intervene. The FDA's decision to lift restrictions on mifepristone had been welcomed by abortion rights advocates, and the Supreme Court's decision on the case could have a major impact on the availability of the drug.

Appeals Court Grants Temporary Reprieve to Access to Abortion Pill Mifepristone

The 5th U.S. Circuit Court of Appeals has granted a temporary reprieve to access to the abortion pill mifepristone, allowing the FDA's initial approval of the drug to remain in place but with tighter rules than before. The ruling leaves considerable uncertainty over access to the drug, but it does provide a temporary solution until the full case is heard.

Appeals Court Partially Grants Request to Freeze Texas Judge’s Order Limiting Access to Mifepristone Abortion Drug

A federal appeals court has partially granted a request to freeze parts of a Texas judge’s order that would have suspended the US Food and Drug Administration’s approval of a medication abortion drug, mifepristone. The court’s order will keep the approval in effect and the drug on the market while an expedited appeal plays out, but under tighter rules that would allow the drug only to be dispensed up to seven weeks, not 10, and not by mail. The decision is expected to be appealed to the Supreme Court.