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Fda

All articles tagged with #fda

politics1 day ago•10 min saved

Pro-Life Coalition Fractures With Trump Over Abortion Pill Access

After the Supreme Court preserved access to telemedicine abortions, anti-abortion groups intensified pressure on the Trump administration to act on abortion pills and funding for Planned Parenthood, pressing meetings with the FDA and DOJ and signaling that failure could hurt GOP turnout in the midterms; they want swift use of powers to curb access, including potential moves like the Comstock Act to ban mail-order abortions and defund Planned Parenthood, though some insiders caution the White House ultimately holds the leverage.

via Politico|

#abortion #fda #mifepristone

health3 days ago•4 min saved

FDA Finds No Definitive Link Between Covid Vaccines and Child Deaths

The FDA reviewed 96 VAERS reports of child deaths through Aug. 14, 2025 and found no cases definitively linked to Covid vaccines; five were labeled possible and two probable, but causality could not be ruled out and VAERS limitations apply. The analysis, prompted by ongoing vaccine safety discussions, notes that most cases involved myocarditis and that infections can also trigger this condition.

via NBC News|

#covid-19-vaccines #fda #health

health4 days ago•18 min saved

FDA vaping policy surprise rattles regulators

The FDA implemented a policy shift to allow more e-cigarettes and nicotine pouches onto the U.S. market, a move that regulators say blindsided staff and critics who warn it could weaken oversight and public health protections, potentially increasing youth access to vaping products.

via AP News|

#e-cigarettes #fda #health

health5 days ago•2 min saved

US Enlists San Diego Biotech for Experimental Ebola Antibody Therapy

The U.S. government has tapped San Diego biotech Mapp Biopharmaceutical to supply doses of the experimental Ebola antibody MBP134 for potential use in high-risk individuals amid a Bundibugyo outbreak; MBP134 was developed with BARDA for Sudan virus and has shown preclinical cross-protection against Bundibugyo; use would be coordinated by the FDA and is not yet approved, with supply details not disclosed.

via Fierce Biotech|

#barda #ebola #fda

health5 days ago•3 min saved

Three-Minute Game May Serve as a Depression Diagnostic Tool

NYU researchers created a three-minute smartphone game to help identify major depression by measuring how people adjust to changing rewards; depressed participants switched trees earlier and bid differently on snacks, signaling distorted expectations and reduced pleasure response, with results correlating to illness severity. The team envisions the game as a remote diagnostic and monitoring tool—potentially prescribed to track treatment efficacy before next in-person visits, pending FDA clearance as a Class II medical device.

via Gizmodo|

#anhedonia #depression #diagnostic-tool

health6 days ago•12 min saved

FDA Reviews Expanded ANKTIVA+BCG Indication for Papillary NMIBC; PDUFA Set for January 2027

ImmunityBio disclosed that the FDA has accepted for review a supplemental Biologics License Application to expand ANKTIVA when combined with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer with papillary disease (no CIS). The FDA assigned a PDUFA target date of January 6, 2027. The submission relies on QUILT-3.032 Cohort B data and literature suggesting papillary NMIBC shares a biological profile with CIS, potentially allowing extrapolation from CIS trials. If approved, the expansion would broaden ANKTIVA+BCG to papillary-only NMIBC, offering a bladder-sparing, immunotherapy option and potentially delaying cystectomy, with safety data consistent with BCG alone and support from NCCN Category 2A guidance.

via ImmunityBio|

#anktiva #bcg #fda

health9 days ago•1 min saved

Straus ice cream recall expands to 17 states over metal contamination risk

Straus Family Creamery is recalling several organic ice creams sold in pint and quart sizes due to potential metal fragments. Affected lots include Vanilla Bean (pint; best by Dec 23 or Dec 28, 2026), Strawberry (quart; best by Dec 24, 2026; pint; Dec 25, 2026), Cookie Dough (pint; Dec 26, 2026), Dutch Chocolate (quart; Dec 27, 2026), and Mint Chip (pint; Dec 30, 2026). The recall covers 17 states; no injuries have been reported; discard the product and do not return to stores. Check the FDA notice for exact lot codes and dates.

via NBC News|

#fda #health #ice-cream

health-care10 days ago•10 min saved

Acting FDA chief seeks pro-life reassurance after Planned Parenthood ties emerge

Acting FDA Commissioner Kyle Diamantas has been telling anti‑abortion leaders he personally opposes abortion while facing questions about past work as outside counsel for a Planned Parenthood Florida clinic (2014–2017) and his later removal from that case for conscience reasons; some filings still list him, prompting skepticism from conservatives. The FDA has pledged a science‑based review of the abortion pill’s REMS and to provide updates, while Diamantas did not respond to questions about the case; the White House defended him amid ongoing debates over mifepristone policy and the agency’s leadership.

via Politico|

#abortion #diamantas #fda

politics11 days ago•5 min saved

White House scrambles to steady HHS leadership ahead of midterms

With leadership turmoil at HHS and the exit of FDA head Marty Makary, the White House is moving to nominate a new FDA commissioner and overhaul senior staff, aiming to reset relations with the agency, shift away from vaccine-focused MAHA priorities, and stabilize operations ahead of the November midterms while balancing GOP lawmakers and pharmaceutical industry pressures.

via CNN|

#fda #hhs #maha-movement

politics11 days ago•8 min saved

Court Keeps Mail-Order Abortion Pill Accessible as Legal Fight Continues

The Supreme Court paused a lower-court ruling that would have required in-person pickup of the abortion pill mifepristone, allowing patients to continue receiving it by mail and via telehealth while Louisiana’s challenge to FDA rules proceeds, a decision issued with dissent from Justices Thomas and Alito. The ruling preserves current access for now but leaves the broader legal battle over medication abortion rules unresolved as the case moves through the courts and across states with bans.

via The Washington Post|

#abortion #fda #mifepristone

health11 days ago•11 min saved

Promising pancreatic cancer drug triggers patient surge ahead of FDA decision

A promising pancreatic cancer therapy, daraxonrasib from Revolution Medicines, has sparked a rapid wave of patient inquiries and clinic access discussions in the US as doctors rush to coordinate expedited FDA review and company-led enrollment; early trial data show a substantial survival improvement compared with standard chemotherapy, but the treatment is not a cure and access involves a multi-step process.

via The Independent|

#breakthrough #daraxonrasib #fda

law11 days ago•4 min saved

Supreme Court Keeps Mail-Order Abortion Pill Access Intact

In a shadow-docket ruling, the Supreme Court blocked the Fifth Circuit’s attempt to ban mail-order mifepristone, keeping nationwide access available for now as Louisiana’s challenge moves back to the Fifth Circuit. The 7-2 decision, with Justices Thomas and Alito dissenting, highlights ongoing clashes between state abortion restrictions, federal drug regulation, and the Comstock Act, while the FDA continues its safety review of mifepristone and the case awaits further appellate action.

via The Guardian|

#abortion #fda #law

politics11 days ago•3 min saved

Court extends pause on abortion-pill restrictions amid ongoing case

The Supreme Court indefinitely extended a freeze on strict new restrictions for dispensing the abortion pill mifepristone while the underlying legal challenge proceeds, providing temporary certainty for pharmacies, telehealth providers, and clinicians. Justices Alito and Thomas dissented. The case will likely return to the 5th Circuit, with the FDA continuing its safety review of the drug’s REMS program and the broader battle over access not yet resolved.

via Axios|

#abortion-pill #fda #mifepristone

us-politics11 days ago•4 min saved

Supreme Court Keeps Mail-Order Abortion Pill Accessible as Case Winds Through Courts

The Supreme Court issued a brief order allowing the abortion pill mifepristone to continue to be prescribed via telehealth and mailed to patients, blocking a Fifth Circuit ruling while litigation continues in lower courts. The decision preserves access for now as Louisiana’s challenge to FDA rules proceeds, with justices Thomas and Alito dissenting; the case centers on whether the FDA’s loosened 2021 regulations were properly grounded amid ongoing safety reviews and regulatory scrutiny.

via The New York Times|

#abortion-pill #fda #louisiana

politics13 days ago•17 min saved

Trump’s Hunting Buddy Named Acting FDA Commissioner

Kyle Diamantas, a Florida lawyer and Don Jr.’s longtime turkey-hunting companion, was named acting FDA commissioner after Marty Makary’s resignation, moving from deputy head of the agency’s human foods program. Although not an MD, his appointment is viewed as a pragmatic interim solution amid FDA leadership turmoil, with Senate confirmation still needed for a permanent post and potential candidates like Admiral Brett Giroir discussed.

via Rolling Stone|

#don-jr #donald-trump #fda