Food and Drug Administration & oral communication
agency of the US Department of Health and Human Services
US FDA approves first drug for fatty liver disease NASH: The U.S. FDA has approved Madrigal Pharmaceuticals' drug for a fatty liver disease known as ...
reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-drug-fatty-liver-disease-nash-2024-03-14/
Quick Glance: First Drug Approval for Fatty Liver Disease NASH by US FDA
- The US FDA has approved Madrigal Pharmaceuticals' drug for the fatty liver disease NASH.
- NASH, now known as metabolic dysfunction-associated steatohepatitis (MASH), affects about 1.5 million Americans.
- The drug will be available in April and is seen as a pivotal moment for patients.
- Other companies are also conducting trials of their drugs for NASH to meet the much-needed treatment.
Madrigal's drug wins first US approval for fatty liver disease NASH as rivals circle
reuters.com/business/healthcare-pharmaceuticals/madrigals-drug-wins-first-us-approval-fatty-liver-disease-nash-rivals-circle-2024-03-14/
US FDA delays Lilly Alzheimer's drug decision, calls for advisory panel: The U.S. Food and Drug Administration has delayed a decision on whether to approve Eli ...
reut.rs/3IrzVpe
FDA delays Alzheimer’s drug for further review in surprise move : Eli Lilly had expected donanemab to be approved this month, but regulators will hold an ...
washingtonpost.com/business/2024/03/08/eli-lilly-alzheimers-donanemab-fda/
Healthy Returns: The first drug for a common, deadly liver disease is here – and more are coming
cnbc.com/2024/03/19/healthy-returns-first-nash-liver-disease-drug-is-here-more-coming.html
Xolair for food allergies: How it works and what it costs: The FDA expanded approval for the asthma drug Xolair for multiple food allergies including peanuts and ...
nbcnews.com/health/health-news/xolair-food-allergies-works-costs-rcna140223
After photos of Mariel Rodriguez’s glutathione drip session at the Senate made rounds online, Senator Robinhood Padilla shrugged off critics of his wife saying ... Show more trib.al/sOw1LEE
When diet and exercise aren’t enough, new drug can treat fatty liver disease, says FDA
cleveland.com/news/2024/03/when-diet-and-exercise-arent-enough-new-drug-can-treat-fatty-liver-disease-says-fda.html
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Getting your hands on the new weight loss meds isn’t simple. Here are 5 things to know
cnn.com/2024/02/15/health/weight-loss-drugs-access-business-wellness/
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Madrigal’s (MDGL) Rezdiffra Gets FDA Approval to Treat NASH Liver Disease: Madrigal Pharmaceuticals Inc.’s drug Rezdiffra gained the first US approval to treat a ...
bloomberg.com/news/articles/2024-03-14/first-drug-to-treat-common-lethal-liver-disease-gets-us-nod
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US delays approval of Eli Lilly Alzheimer's treatment: Lilly said no date has been set yet for the advisory committee meeting to discuss the medicine ...
irishexaminer.com/business/companies/arid-41348894.html
FDA renews debate over biased pulse oximeters: The pandemic revealed how the devices' struggles in patients with darker skin led to treatment delays.
axios.com/2024/02/02/fda-pulse-oximeters-dark-skin-black-brown
Choose balanced diet over vitamin C drips, which can cause kidney failure: DOH: Choose balanced diet over vitamin C drips, which can cause kidney failure: DOH
news.abs-cbn.com/lifestyle/2024/2/26/choose-balanced-diet-over-vitamin-c-drips-which-can-cause-kidney-failure-doh-1728
What to consider before starting the new weight loss medications: The world of weight loss has changed drastically with medications like Wegovy ...
cnn.com/2024/01/17/health/weight-loss-medication-what-best-wellness/
Expert meeting to be held in tainted Taisugar pork case: FDA - Focus Taiwan: Taipei, Feb. 16 (CNA) Experts will meet on Feb. 21 to discuss how the banned ...
focustaiwan.tw/society/202402160016
FDA confirms additive finding in lone pork sample: Bringing Taiwan to the World and the World to Taiwan
taipeitimes.com/News/taiwan/archives/2024/02/07/2003813219
Biogen to shut down controversial Alzheimer's drug Aduhelm: Biogen will stop selling its Alzheimer’s treatment Aduhelm. The drug was once seen as a potential ...
apnews.com/article/biogen-alzheimer-aduhelm-dfb364a61e4e77da27fc055e826b9a49
Quick Glance: Biogen Halts Production of Alzheimer’s Drug Aduhelm
- Biogen halts production of Alzheimer’s drug Aduhelm, focusing on Leqembi and developing other treatments for the disease.
- The decision to end development of the drug was not related to safety or efficacy concerns.
- The US Food and Drug Administration will end its study needed for full approval of the drug.
- The US Congress criticized the collaboration between Biogen and the FDA, concluding that the high price of the drug was unjustified.
New At-Home STI Test Could Help Stop the Spread of Infection: Experts hope a recent FDA approval for the first commercial at-home test for sexually transmitted ...
scientificamerican.com/article/new-at-home-sti-test-could-help-stop-the-spread-of-infection/
J.P. Morgan Healthcare Conference comes as biotech rout persists: As more than 8,000 biotech executives, investors and analysts converge this week for the 42nd ...
bostonglobe.com/2024/01/07/business/jp-morgan-healthcare-conference-san-francisco-biotech/
A surgeon general report once cleared the air about smoking. Is it time for one on vaping?
stltoday.com/news/nation-world/government-politics/smoking-vaping-surgeon-general/article_f678e8ca-0eaa-52a4-92c1-40b71d44ff9c.html
Everything you need to know about artificial wombs: Artificial wombs are nearing human trials. But the goal is to save the littlest preemies ...
technologyreview.com/2023/09/29/1080538/everything-you-need-to-know-about-artificial-wombs/
Is abortion access in peril (even where it's legal)? Supreme Court case could tip balance.
usatoday.com/story/news/health/2023/12/14/supreme-court-abortion-pill-case-update/71906149007/
Quick Glance: Lack of Compassion in Abortion Discourse
- The abortion discourse has led to a lack of compassion in society.
- We have ceased to consider those seeking abortion as parents or as individuals doing their best given the circumstances.
- Many individuals will use the story of the Kate Cox family as a basis for further debating abortion.
- Others will undoubtedly pass judgment if the family even considers ending the life of their unborn child.
‘Patent cloud’ hangs over CRISPR therapy: A long-running dispute over intellectual property rights for the CRISPR technology at the heart of the first-ever ...
politico.com/newsletters/prescription-pulse/2023/12/12/patent-cloud-hangs-over-crispr-therapy-00131243
Biden administration opens public comments on strategy to combat food waste - UPI.com
upi.com/Top_News/US/2023/12/05/agriculture-department-announces-food-waste-reduction-strategy/6581701793009/
Apple to pause selling new versions of its watch after losing patent dispute: After losing a patent case over the technology used to detect a pulse rate ...
nytimes.com/2023/12/18/technology/apple-ban-watch-sales-patent-dispute.html
Quick Glance: Apple to Launch Vision Pro in February
- Production has been at full speed to ensure Vision Pro is ready by January end, with a retail launch planned for February.
- Sales of Vision Pro will be limited to the United States initially, requiring customers to visit a retail store or pick up an online order in store.
- Apple wants to ensure customers have the right headband size and Light Seal for an appropriate fit.
- Apple is preparing to display and demonstrate Vision Pro in some of its retail stores.
US FDA staff flags concerns about Merck's chronic cough drug: The U.S. health regulator's staff on Wednesday flagged concerns that data on Merck's (MRK ...
reuters.com/business/healthcare-pharmaceuticals/us-fda-staff-flags-concerns-mercks-chronic-cough-drug-2023-11-15/
Trial confirms heart benefits of Wegovy, but is weight loss responsible – or something else?
cnn.com/2023/11/11/health/wegovy-cardiovascular-events/
FDA Deputy Commissioner Janet Woodcock to Retire: US Food and Drug Administration Deputy Commissioner Janet Woodcock will retire next year after nearly four ...
bloomberg.com/news/articles/2023-11-16/fda-deputy-commissioner-janet-woodcock-to-retire-next-year
US FTC disputes over 100 medical patents listed with FDA including asthma inhalers
reuters.com/business/healthcare-pharmaceuticals/us-ftc-disputes-listing-more-than-100-patents-fda-orange-book-2023-11-07/
FDA panel weighs CRISPR-based sickle cell therapy: The FDA must decide whether to approve the therapy by Dec. 8.
axios.com/2023/11/01/fda-crispr-sickle-cell-therapy
Quick Glance: FDA examines Sickle cell gene therapy
- A bone marrow transplant is the only cure for the painful sickle cell disease today.
- On Tuesday, the Food and Drug Administration will review a gene therapy for the inherited blood disorder, primarily affecting Black individuals in the U.S.
- The agency is expected to make a decision regarding the treatment in early December and consider another sickle cell gene therapy later that month.
- Scientists believe that carrying the sickle cell trait provides protection against severe malaria.
The FDA Should Approve Sickle Cell Disease Crispr Therapy: The gene-editing treatment has been transformative for patients with sickle cell disease ...
bloomberg.com/opinion/articles/2023-11-01/the-fda-should-approve-sickle-cell-disease-crispr-therapy
Getting prescription drugs online is so easy. Are regulators paying attention?: Telehealth prescribers flourish in the wake of the pandemic, regulatory gaps and ...
undark.org/2023/11/01/telehealth-drugs/
Biden administration looking to expand coverage of OTC birth control, other products
thehill.com/policy/healthcare/4230771-biden-administration-looking-to-expand-coverage-of-otc-birth-control-other-products/
FDA advisers vote against experimental ALS treatment pushed by patients: Federal health advisers have voted overwhelmingly against recommending approval of an ...
apnews.com/article/als-nurown-fda-lou-gehrigs-disease-1884a8704d5f5d251f42301dd5eda696
How Did an Ineffective Cold Medication Get So Popular?: Studies prove that popular decongestants just don’t work.
theatlantic.com/health/archive/2023/09/cold-medicine-decongestant-phenylephrine-ineffective/675303/
US FDA to seek public opinion before banning popular cough syrup ingredient: The U.S. Food and Drug Administration said on Thursday it would seek public opinion ...
reuters.com/world/us/us-fda-seek-public-opinion-before-deciding-disallowing-popular-cough-syrup-2023-09-14/
Abortion pill manufacturer asks Supreme Court to ensure access to medication: The request creates an opening for the Supreme Court to decide when and how ...
washingtonpost.com/politics/2023/09/08/abortion-pill-supreme-court-appeal-mifepristone/
Quick Glance: Mexico's Supreme Court Decriminalizes Abortion
- Abortion remains illegal in two-thirds of Mexican states, but people in those states can now access abortions at federal medical facilities without facing penalties from the states.
- This is part of a wave of victories for abortion rights in Latin America.
- Colombia, Argentina, Uruguay, and Guyana have also taken steps to legalize or decriminalize abortion.
Artificial Wombs That Could Help Premature Babies Will Meet FDA Scrutiny: Next week, regulators will debate a device that aims to help extremely premature babies ...
bloomberg.com/news/articles/2023-09-14/artificial-wombs-that-could-help-premature-babies-will-meet-fda-scrutiny
Decongestant used by Sudafed, Benadryl is not effective, FDA advisers find: A Food and Drug Administration (FDA) advisory committee unanimously voted Tuesday ...
thehill.com/homenews/4200317-decongestant-used-by-sudafed-benadryl-is-not-effective-fda-advisers-find/
Supreme Court is asked to reject limits on a drug used in the most common method of abortion
apnews.com/article/supreme-court-abortion-pill-mifepristone-fda-approval-c673116607517af1e0e0f9ba95d0f9df
Eggs pass labeling inspections: FDA: Bringing Taiwan to the World and the World to Taiwan
taipeitimes.com/News/taiwan/archives/2023/10/05/2003807243
The appointment comes as the US FDA recovers from a bruising controversy over its role in a nationwide shortage of infant formula. Show more
As of Tuesday, conversations with congested patients began to change, when the Food and Drug Administration’s Nonprescription Drugs Advisory Committee made a ... Show more
Slog AM: No Charges for Seattle Leaders in Deleted Text Scandal, Seattle Committee Votes to Restart Drug War, Dam Bursts in Libya Kill 5,000
thestranger.com/slog-am/2023/09/13/79165609/slog-am-no-charges-for-seattle-leaders-in-deleted-text-scandal-seattle-committee-votes-to-restart-drug-war-dam-bursts-in-libya-kill-5000
Abortion, spending fights snag FDA spending bill: The first health-related spending bill to go through the House this year was pulled from the floor schedule.
axios.com/2023/07/28/abortion-fight-snags-fda-spending-bill
US FDA taps EPA veteran James Jones to oversee food division after formula crisis
reuters.com/business/healthcare-pharmaceuticals/us-fda-taps-epa-veteran-james-jones-oversee-food-division-after-formula-crisis-2023-08-23/
‘Enforcing doctors to prescribe only generic medicines is ill-advised and irrational’
financialexpress.com/healthcare/pharma-healthcare/enforcing-doctors-to-prescribe-only-generic-medicines-is-ill-advised-and-irrational/3214794/
WeightWatchers Is Gambling Everything on Obesity Drugs: Ozempic and Wegovy might save the 60-year-old company—if they don’t kill it first.
bloomberg.com/news/features/2023-07-19/weightwatchers-new-ceo-pushes-points-and-obesity-drugs
FDA advisers endorse updating COVID vaccines to target latest omicron strain: The COVID-19 vaccines are on track for a big recipe change this fall ...
apnews.com/article/covid19-vaccine-booster-shot-coronavirus-fall-72c0436ac9211f1a893fe8056106909d
Alzheimer's drug gets FDA panel's backing, setting the stage for broader use: WASHINGTON (AP) — Health advisers on Friday unanimously backed the full approval of ...
apnews.com/article/leqembi-alzheimers-drug-fda-f438cd0d1df98d1df0677a219cee6fa7
US FDA panel backs approval for Eisai-Biogen Alzheimer's drug Leqembi: A panel of expert advisers on Friday unanimously agreed that a late-stage trial of Eisai ...
reuters.com/business/healthcare-pharmaceuticals/fda-panel-debate-us-approval-alzheimers-drug-eisai-biogen-2023-06-09/
First over-the-counter birth control pill gets FDA approval: U.S. officials have approved the first over-the-counter birth control pill, a major change that will ...
apnews.com/article/birth-control-pills-without-prescription-fda-b6728e98af5f1625520e0fa5fbc911c3
Quick Glance: First Over-the-Counter Birth Control Pill Approved in the U.S.
- Survey shows that over three-quarters of women of reproductive age prefer an over-the-counter pill.
- Women already taking birth control pills, women without health insurance, and Hispanic women are most likely to choose the product.
- Experts agree that the benefits of an over-the-counter birth control pill outweigh the risks.
- Opill could be safest for adolescents and provide them with a more effective method than condoms and other over-the-counter birth control products.
FDA advisers endorse targeting XBB variant in new COVID booster: An expert panel of the Food and Drug Administration today endorsed updating COVID boosters for ...
axios.com/2023/06/15/covid-boosters-vaccine-fda-strain
White House meets with drug firms on cost of overdose-reversal drugs: One drugmaker said it was committed to expanding access to naloxone for “millions of ...
washingtonpost.com/health/2023/06/20/narcan-price-white-house/
FDA panel unanimously votes in favor of RSV antibody treatment for infants: The Food and Drug Administration’s (FDA) antimicrobial drug advisory panel on ...
thehill.com/policy/healthcare/4041416-fda-panel-unanimously-votes-favor-rsv-antibody-treatment-infants/
US FDA panel backs Sanofi-AstraZeneca's preventive RSV therapy: The U.S. Food and Drug Administration advisers on Thursday backed the use of Sanofi (SASY ...
reuters.com/business/healthcare-pharmaceuticals/us-fda-panel-backs-sanofi-astrazenecas-preventive-rsv-therapy-2023-06-08/
#VantageOnFirstpost : Alzheimer's disease is a memory-robbing, incurable disease. And now it has a medicine that can slow it down. "Leqembi" has become the fist ... Show more
What Does Good Psychedelic Therapy Look Like?: As MDMA and psilocybin treatments become more mainstream, the therapy component has come under scrutiny ...
nytimes.com/2023/06/03/well/mind/psychedelic-therapy.html
Two trade unions signal potential breakthrough in dispute with government : Prospect halts planned walkout while FDA suspends ballot for strike action
ft.com/content/f4835d19-a855-4b00-b64e-4d2812a1d506
Paid articlePaid FDA advisers back RSV vaccine for pregnant women that protects their newborns: WASHINGTON (AP) — A first-of-its-kind RSV vaccine for pregnant women guards their ...
apnews.com/article/rsv-vaccine-respiratory-syncytial-virus-pregnant-42330f5b3ce608f9c5b1f4d8ed91594f
US FDA panel votes against approval of Intercept fatty liver drug, cites safety issues
reuters.com/business/healthcare-pharmaceuticals/us-fda-panel-votes-against-accelerated-approval-intercept-fatty-liver-drug-2023-05-19/
Appeals court appears likely to restrict access to key abortion pill : The hearing was the next chapter in a high-stakes legal battle over access to mifepristone ...
washingtonpost.com/politics/2023/05/17/abortion-pill-appeal-court-arguments/
Quick Glance: Appeals Court Skeptical of FDA’s Approval and Regulation of Abortion Pill
- A widely used abortion pill may face restricted availability due to a potential court ruling.
- Anti-abortion groups argued for the withdrawal of federal approval for the drug in front of a panel of three judges.
- The court appeared skeptical of the government's defense of the abortion drug during a two-hour hearing in New Orleans.
- A federal appeals court showed skepticism of the Food and Drug Administration's decisions about the commonly used abortion pill.
Over-the-counter birth control pill unanimously approved by FDA panel
theweek.com/public-health/1023433/fda-advisers-vote-unanimously-to-make-birth-control-pill-available-over-the
Quick Glance: FDA Panel Recommends First Nonprescription Birth Control Pill
- A U.S. Food and Drug Administration (FDA) expert panel unanimously voted to make an oral contraceptive pill available over-the-counter.
- If the FDA adopts the panel’s recommendation, the birth control pill will become the first oral contraceptive women can take without medical supervision.
- The committee’s decision was heavily influenced by the need for an accessible form of nonprescription contraception that’s more effective than currently available methods like condoms.
- The committee concluded that the potential benefits of over-the-counter birth control pills, including increased access to birth control and fewer unintended pregnancies, outweighed the potential risks of inappropriate use.
Birth Control Pill Gets Strong Endorsement for Over-the-Counter Access: Scientific American is the essential guide to the most awe-inspiring advances in science ...
nature.com/articles/d41586-023-01580-2
Pfizer, GSK Shots for RSV Get Backing for Older Adults: Shots from Pfizer Inc. and GSK Plc that prevent respiratory syncytial virus got backing from a panel of ...
bloomberg.com/news/articles/2023-06-21/pfizer-pfe-gsk-gsk-shots-for-rsv-get-backing-for-use-in-older-adults
Quick Glance: GSK Reports Long-Term Protection from RSV Vaccine in Adults After Late-Stage Trial
- GSK announced that their RSV vaccine provides long-term protection for older adults after receiving a single shot.
- The results come from the company's late-stage clinical trial involving approximately 25,000 individuals.
- The vaccine also provides long-lasting protection for individuals with underlying health conditions or advanced age.
- RSV vaccines for older adults may be introduced this season.
FDA panel backs over-the-counter birth control pill: WASHINGTON (AP) — Federal health advisers said Wednesday that a decades-old birth control pill should be ...
apnews.com/article/birth-control-pills-without-prescription-fda-d6e863b0d41a8c6c783c569773efa349
FDA panel recommends jab for pregnant mothers to prevent RSV in infants: FDA panel recommends jab for pregnant mothers to prevent RSV in infants
wionews.com/world/fda-panel-recommends-jab-for-pregnant-mothers-to-prevent-rsv-in-infants-594134
FDA advisers narrowly back first gene therapy for muscular dystrophy: A panel of experts voted 8-6 in favor of Food and Drug Administration approval of the first ...
npr.org/sections/health-shots/2023/05/12/1175852294/fda-advisers-narrowly-back-first-gene-therapy-for-muscular-dystrophy
House panel moves FDA funding bill with abortion and tobacco riders: The House Appropriations subcommittee in charge of FDA funding easily approved a fiscal 2024 ...
axios.com/2023/05/19/house-fda-funding-abortion-tobacco
Sarepta surges after FDA panel backs Duchenne gene therapy: Shares of Sarepta Therapeutics (SRPT.O) jumped 25% on Monday as a backing by the U.S ...
reuters.com/business/healthcare-pharmaceuticals/sarepta-surges-after-fda-panel-backs-duchenne-gene-therapy-2023-05-15/
Red Dye No. 3: A candy-colored controversy: Are maraschino cherries a menace?
qz.com/emails/quartz-obsession/1850538611/red-dye-no-3-a-candy-colored-controversy
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Biogen Stock Rises After Panelists Sign Off On Alzheimer's Drug: Biogen stock rose Monday after a panel of advisors to the FDA voted unanimously in favor of its ...
investors.com/news/technology/biogen-stock-halted-as-fda-panelists-mull-alzheimers-treatment/
India Needs to Restore Faith in the ‘World’s Pharmacy’: The country will never be a true export power if customers cannot trust the safety and efficacy of its ...
bloomberg.com/opinion/articles/2023-06-11/india-s-generic-drugs-need-better-oversight
India Needs to Restore Faith in the ‘World’s Pharmacy’: The country will never be a true export power if customers cannot trust the safety and efficacy of its ...
bloomberg.com/opinion/articles/2023-06-11/india-s-generic-drugs-need-better-oversight
AstraZeneca, Sanofi Win FDA Advisers’ Backing for Infant RSV Drug: AstraZeneca Plc’s and Sanofi’s drug to prevent respiratory syncytial virus won support from a ...
bloomberg.com/news/articles/2023-06-08/astra-azn-ln-sanofi-san-fp-win-backing-of-key-fda-panel-for-infant-rsv-drug
AI and machine learning may speed drug development, manufacturing: FDA: The FDA published two discussion papers this week about areas artificial intelligence and ...
foxbusiness.com/technology/ai-machine-learning-may-speed-drug-development-manufacturing-fda
What's next with COVID-19 boosters: An FDA panel will soon consider what this fall's COVID boosters will look like.
axios.com/2023/05/04/covid-boosters-omicron-moderna-pfizer-fda
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