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Myasthenia Gravis Gets a New Drug Approval
FDA expands inebilizumab's indication to include gMG
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The FDA expanded the indication of inebilizumab (Uplizna) to include generalized myasthenia gravis, Amgen announced Friday.
www.medpagetoday.com/neurâŚ
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Big retailers didnât pull ByHeart baby formula fast enough
apnews.com/article/byhe...
apnews.com
Big retailers didn't pull ByHeart baby formula fast enough after botulism recall, FDA says
The U.S. Food and Drug Administration sent warning letters to four top retail stores for failing to promptly pull contaminated infant formula tied to a dangerous outbreak from their shelves.
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Another study finds big benefits to getting a COVID vaccine during pregnancy. So why might the FDA add a black box warning to Covid shots?
âI just don't think that these are âOopsy!â accidental leaks. Theyâre testing the waters to see how far they can go.â
www.cidrap.umn.edu/covid-âŚ.
www.cidrap.umn.edu
Pregnant women vaccinated against COVID-19 less likely to be hospitalized or deliver prematurely, new data show
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Andexanet alfa (Andexxa) will officially be taken off the U.S. market this month as an emergency reversal medication for contemporary blood thinners.
www.medpagetoday.com/publâŚ
www.medpagetoday.com
Anticoagulant Reversal Drug Pulled From U.S. Market
Andexanet alfa (Andexxa) was denied full FDA approval last year
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The Kansas City maker of 7-OH is fighting a federal forfeiture case filed against it in November.
bit.ly
American Shaman: FDA seizure is âfearmongeringâ and a ârush to judgmentâ
The Kansas City maker of 7-OH is fighting a federal forfeiture case filed against it in November.
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Marijuana is considered a Schedule I drug under the Food and Drug Administrationâs classification of controlled substances. The FDA defines drugs on the list, such as heroin and cocaine, as lacking any medicinal value and carrying a high likelihood of abuse.
azmirror.com
Trump 'very strongly' considering loosening federal marijuana regulations | Arizona Mirror
President Trumpâs administration is looking âvery stronglyâ at reclassifying marijuana from the strictest category of controlled substances.
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AstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment reut.rs/48WyyMf
reut.rs
AstraZeneca, Daiichi's breast cancer drug gets FDA nod as first-line treatment
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's Enhertu in combination with Roche's drug, Perjeta, for the first-line treatment of patients with a type of breast cancer, the regulator said on Monday.
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Big retailers didnât pull ByHeart baby formula fast enough after botulism recall, FDA says
www.seattletimes.com
Big retailers didnât pull ByHeart baby formula fast enough after botulism recall, FDA says
The U.S. Food and Drug Administration sent warning letters to four top retail stores for failing to promptly pull contaminated infant formula tied to a dangerous outbreak from their shelves.
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US FDA sends warning letters to Walmart, Target for selling recalled baby formula reut.rs/4iVqnUK
reut.rs
US FDA sends warning letters to Walmart, Target for selling recalled baby formula
The FDA said four major retailers continued to sell baby formula linked to a nationwide outbreak of bacterial illness in infants even after the products were recalled.
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In this week's roundup, updates on the many abortion pill lawsuits, a "blue" state governor poised to make some not-so-progressive moves, and the Hawleys are at it again:
www.autonomynews.co
Florida and Texas Sue the FDA, Planned Parenthood Loses Appeal, and More: December 15 News Roundup
Plus, Josh and Erin Hawley launch a new dark money group.
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FDA Commissioner Martin Makary discusses vaccine policy, COVID-era decisions and the erosion of trust in government health guidance. n.pr/4sdT0B4
n.pr
FDA commissioner on growing public mistrust of government health advice
FDA Commissioner Martin Makary discusses vaccine policy, COVID-era decisions and the erosion of trust in government health guidance.
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đ¨ UPDATE: The @fda.gov has approved a new therapy for #marginalzonelymphoma. The approval is based on results from a phase 2 clinical trial led by Dr. Lia Palomba, a hematologist-oncologist at MSK.
Learn more: bit.ly/4iVd9Y6
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The @US_FDA approved the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the first-line treatment of certain adults with unresectable or metastatic HER2-positive breast cancer: buff.ly/mxnplwh
www.fda.gov
FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unres
On December 15, 2025, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) in combination with pertuzumab f
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Augmentin XR becomes first drug to receive FDA approval through Commissionerâs National Priority Voucher Pilot Program
cancerletter.com/drugs-anâŚ
cancerletter.com
Augmentin XR becomes first drug to receive FDA approval through Commissionerâs National Priority Voucher Pilot Program - The Cancer Letter
FDA approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissionerâs National Priority Voucher pilot program, marking the first approval achieved through this review pathway. To access this subscriber-only content please log in or subscribe.If your institution has a site license, log in with IP-login or register for a sponsored account.**Not all site licenses are enrolled in [âŚ]
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Absence of Bureaucracy at FDA Is ruining its effectiveness and competence: Large organizations don't work so well without consultation, deliberation, transparency and stability, and FDA lacks them right now. www.biospace.com/policy/aâŚ.
www.biospace.com
Absence of Bureaucracy at FDA Is Shooting Pharma in the Foot
With five CDER leaders in one year and regulatory proposals coming âby fiat,â the FDA is only making it more difficult to bring therapies to patients.
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The FDA under MAHA control: Weakening the quack Miranda warning on supplements (and a double standard: impossible testing standard for vaccines, none for supplements) sciencebasedmedicine.org/âŚ. via @sciencebasedmedicine.org @gorskon.bsky.social
sciencebasedmedicine.org
The FDA under MAHA control: Weakening the quack Miranda warning on supplements
The FDA sent a letter to the supplement industry assuring that it would make it easier for them to hide disclaimers (which we like to call "quack Miranda warnings") about unproven health claims for su
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Chaos At The FDA Benefits Americaâs RivalsâAt The Expense Of Americaâs Patients www.forbes.com/sites/sallyp...
www.forbes.com
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FDA Approval: fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer
Based on DESTINY-Breast09
www.fda.gov/drugs/drug-a...
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As @gorskon.bsky.social discussed today.
sciencebasedmedicine.org/âŚ.
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FDA OKs libido-boosting pill for women who have gone through menopause
www.seattletimes.com
FDA OKs libido-boosting pill for women who have gone through menopause
U.S. health officials have expanded approval of a drug that boosts libido in women who report stress due to a low sex drive.
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The FDA is considering a rule change that would cut back on how often dietary supplement warnings must appear on packaging, a move experts say could make them easier to miss.
nbcnews.to
FDA says it may relax warning label rule for dietary supplements
Supplements arenât reviewed for safety and effectiveness, but disclaimers about health benefits are required on products.
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BREAKINGđ¨: @fda.gov Approves First-Line T-DXd Plus Pertuzumab for HER2+ Breast Cancer #bcsm #oncology www.onclive.com/view/fda-âŚ.
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"When we drilled deeper, the picture became even more troubling."
Read the #OpEd from Robert Kaplan, PhD, MA, Amanda J Koong, MS, and Veronica Irvin, PhD, MPH, at: www.medpagetoday.com/opinâŚ
www.medpagetoday.com
Opinion | Lowering FDA's Drug-Approval Standards Is a Lose-Lose
Requiring just one trial will neither speed approvals nor support safety
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