#FDA News

PhRMA cries foul on CMS' registry approach for Alzheimer's drugs
fiercepharma.com As Biogen and Eisai’s second Alzheimer’s drug Leqembi nears a potential full FDA approval, the Centers for Medicare and Medicaid Services (CMS) this week

FDA allows temporary import of unapproved Chinese cancer drug to ease U.S. shortage
cnbc.com Worker labors on a production line at factory of Qilu Pharmaceutical (Hainan) Co Ltd on February 11, 2022 in Haikou, Hainan Province of China. The Food and Drug…

I Worked Side By Side With Elizabeth Holmes. She Seemed Like a Visionary, but We Were All Duped
entrepreneur.com "Silicon Valley's 'fake it until you make it' mentality. That rhetoric is just a way to condone lying to people." This as-told-to essay is based on a transcribed…

Is berberine good alternative to Ozempic for weight loss?
newsweek.com A dietary supplement has become the hottest new weight loss trend. It's been hailed by many as the "Ozempic of nature." But what does berberine do to the body, and can it…

Novartis Kisqali® significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful…
novartis.com Kisqali is the first and only CDK4/6 inhibitor to demonstrate a consistent, clinically meaningful benefit across a broad population of patients with HR+/HER2- early breast…

America's most popular artificial sweetener damages our DNA, scientists say
newsweek.com Sugar is always made out to be the bad guy. But, when it comes to your health, switching to artificial sweeteners might be doing more harm than good. Researchers from North…

Offer made to civil servants in bid to end strikes
bbc.co.uk The government has made a new offer in a bid to end a dispute over pay and jobs with civil servants, union bosses have said. Unions said as well as the lump sum, the deal…

States sue 3M, DuPont over toxic 'forever chemicals' found in drinking water
cnbc.com Just outside of Bangor, Maine — the hometown of renowned horror author Stephen King — more than 500 students, faculty and staff arrive at Hermon High School each day. But…

What it was like to work closely with Elizabeth Holmes at Theranos
businessinsider.com He shared what it was like to experience the company's rise and fall from the inside. • "Seeing those people be brought to justice is a comfort," he said of Holmes going to…

Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch
fiercepharma.com About a month after GSK won the world's first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. | After winning FDA approvals one…

FDA finalizes limit on how much arsenic can be in apple juice
cnn.com The US Food and Drug Administration has finalized guidance on the maximum amount of inorganic arsenic that can be in apple juice. The announcement that came Thursday…

New Alzheimer's drugs to be covered by Medicare, if FDA approved
nbcnews.com The Centers for Medicare & Medicaid Services said Thursday that it will pay for new Alzheimer’s drugs that are granted full approval from the Food and Drug Administration,…

FDA: Don’t use off-brand versions of popular weight loss drugs
thehill.com The Food and Drug Administration (FDA) warned consumers this week not to use off-brand versions of popular weight-loss drugs Ozempic, Rybelsus and Wegovy, saying they may…

CMS makes it official: Coverage for new Alzheimer's drugs once full approvals arrive
endpts.com As Congressional and advocacy group pressure has been heated, the Centers for Medicare and Medicaid Services reaffirmed today that if amyloid-targeted drugs to slow the…

FDA warns about safety of 'off-brand' versions of Ozempic, Wegovy
goodmorningamerica.com The FDA said it's received reports of adverse events after people took semaglutide that came from a compounding pharmacy. It did not specify the number of reports or what…

Is Pfizer Stock A Buy As It Leaps Into The Red-Hot Weight-Loss Race?
investors.com stock bounded higher in mid-May on enthusiasm for its potential rival to Novo Nordisk (NVO) and Eli Lilly (LLY) in diabetes treatment and weight loss. Pfizer tested its…

The FDA just set arsenic levels for apple juice. The level could hurt kids, Consumer Reports says
cbsnews.com The U.S. Food and Drug Administration has set limits for inorganic arsenic in apple juice, but Consumer Reports argues that the level is still too high and could harm…

Medicare details plan to cover Alzheimer's treatments
cnbc.com Medicare Part B will cover treatments for Alzheimer's disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the…

Got beef?
morningbrew.com There’s a fight brewing in the dairy aisle: The viral Aubrey Plaza “Wood Milk” ad stands accused of breaking federal law by unfairly going after plant-based beverages. The…

FDA discourages taking off-brand versions of weight-loss drugs Ozempic and Wegovy
fortune.com The U.S. Food and Drug Administration is warning consumers not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy because they might not contain…

AZ, Merck's Lynparza wins FDA nod in prostate cancer subgroup following advisory committee vote
fiercepharma.com After a panel of independent experts endorsed a narrow approval for AstraZeneca and Merck’s Lynparza in metastatic castration-resistant prostate cancer (mCRPC), the FDA has…

FDA considers temporary cancer drug imports from unapproved companies to ease U.S. shortage
cnbc.com WINDSOR, ON - MAY 8: Registered Pharmacy Technician Dawn Deslippe carefully labels Diane's dose of Carboplatin, one of two chemo drugs she will receive on this visit. Every…

FDA warns consumers not to use off-brand versions of Ozempic, Wegovy
go.com The U.S. Food and Drug Administration is warning consumers not to use off-brand versions of the popular weight-loss drugs Ozempic and Wegovy because they might not contain…

FDA approves RSV vaccine for older adults
axios.com The Food and Drug Administration on Wednesday approved Pfizer's vaccine against respiratory syncytial virus for people aged 60 and older, making it the second RSV shot…
Biogen Hits Buy Zone On A Fresh Win In Alzheimer's Disease; Eli Lilly, Eisai Shares Jump
investors.com stock jumped into a buy zone Thursday after Medicare officials said they would reimburse patients for the cost of Alzheimer's treatments that target an abnormal protein…
How Biohaven Is Coming 'Out Of Stealth Mode'
investors.com is coming "out of stealth mode," an analyst said Thursday as BHVN stock climbed for a fourth consecutive day. X The company held a meeting outlining its research and…

20 Best Healthcare Dividend Stocks to Invest in
marketbeat.com Investing in the healthcare sector is like having a prescription for long-term wealth. As the demand for innovative treatments, life-saving drugs and cutting-edge medical…

Medicare to expand coverage for a new class of costly Alzheimer’s drugs
washingtonpost.com Medicare officials announced plans Thursday to broadly cover a new class of Alzheimer’s drugs following an intense lobbying campaign by patient advocates and drugmakers…

Thursday briefing: House passes debt ceiling deal; Trump documents; how to watch the NBA Finals; NASA’s UFO findings; and more
washingtonpost.com Thursday briefing: House passes debt ceiling deal; Trump documents; how to watch the NBA Finals; NASA’s UFO findings; and more • None What are they? The first medications…

FDA approves Pfizer RSV vaccine for older adults
thehill.com The Food and Drug Administration (FDA) on Wednesday approved Pfizer’s vaccine to prevent the respiratory disease RSV in older adults, the company announced. After decades…

Awkward Rewind: When Jim Cramer Called Elizabeth Holmes The Next Steve Jobs On TV
benzinga.com Tainted Theranos founder Elizabeth Holmes started an 11-year sentence in a federal prison in Texas this week. The news triggered memories of her once being celebrated as a…

What is berberine, the supplement dubbed 'nature's Ozempic' on social media?
nbcnews.com A dietary supplement called berberine is gaining momentum on social media for its weight loss effects, even being referred to by some as “nature’s Ozempic,” in reference to…

FDA Approves Pfizer’s RSV Vaccine For Older Adults
forbes.com The Food and Drug Administration on Wednesday approved Pfizer’s vaccine to protect older adults from RSV, weeks after the agency greenlit the very first shot against the…

AbbVie's Rinvoq passes midstage test in systemic lupus erythematosus, heads into phase 3
fiercepharma.com AbbVie's Rinvoq is delivering blockbuster sales and driving growth for the drugmaker after its January loss of exclusivity for top-selling Humira. | AbbVie's Rinvoq has been…

FDA Approves Pfizer’s RSV Vaccine for Adults 60 and Older
nytimes.com Why It Matters: Older adults are at a higher risk. Each year, about 60,000 adults 65 and older are hospitalized with R.S.V. and about 6,000 to 10,000 die from the virus, the…

Food poisoning often caused by sick restaurant workers, CDC says
washingtonpost.com Food workers who clock in when sick cause a significant share of food-borne illness, the Centers for Disease Control and Prevention said in a new report, and many…

Ozempic Craze Has Spawned a Sketchy Black Market, FDA Warns
gizmodo.com The Food and Drug Administration is warning people to stay away from suspect sources of semaglutide, the active ingredient in popular weight loss drugs Wegovy and Ozempic.…

Foodborne illness outbreaks at restaurants often linked to sick workers, CDC finds
nbcnews.com Sick employees are major contributors to the spread of foodborne illnesses at restaurants and other food establishments, according to a Centers for Disease Control and…

FDA approves Pfizer’s RSV shot for older adults, teeing up a competitive $17B vaccine market
endpts.com The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.…

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy
fiercepharma.com In the rush to supply prescriptions of Novo Nordisk’s popular diabetes and weight loss meds, some pharmacies are making unauthorized versions of Ozempic and Wegovy, the FDA

GSK’s CEO says you need thick skin if you’re going to step into the C-suite
fortune.com On this week’s episode of Fortune‘s Leadership Next podcast, co-hosts Alan Murray and Michal Lev-Ram talk with GSK CEO Emma Walmsley about the future of A.I. in the…

FDA warns about compounded versions of semaglutide, used for diabetes, weight loss
ksltv.com The US Food and Drug Administration issued a warning Tuesday about compounded versions of the drug semaglutide, which is approved for the treatment of diabetes and excess…

The How and Why of Investing in Biotech Stocks
marketbeat.com Have you been wondering how to invest in biotech stocks? You may have watched biotechs rallying fast and posting significant gains and felt you missed out. You may have also…

The Aubrey Plaza ad for Big Dairy that may have violated federal law, explained
vox.com Aubrey Plaza in an advertisement for a fake company called Wood Milk, on behalf of the Milk Processor Education Program (MilkPEP). | Milk Processor Education Program…
Marker Therapeutics Reports Pre-Clinical Data of its MT-601 MultiTAA-Specific T Cell Product Candidate in Lymphoma Cells
yahoo.com HOUSTON, May 31, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T…

Mood-Altering Mushroom Sales Bloom Despite Safety Concerns
nakedcapitalism.com Yves here. Psychedelics have a very long history in religious ceremonies and more recently in self-discovery. But these mushroom sales have many of the worst aspects of…

FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information
fda.gov Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the U.S. Food and…

Some Americans are reaching for sunscreens made outside the U.S. Here's what skincare experts think about it
cbsnews.com Sunscreen with an SPF of 30 or higher is your best defense against the sun's harmful rays — but is your sunscreen falling behind other options available around the world?…

The urgent American blood shortage, explained
theweek.com Since the start of the pandemic, blood banks across the United States have been calling on eligible donors to come down and help stave off shortages. It's critical that…

Oppenheimer Sees Over 50% Gains in These 2 Stocks
yahoo.com The shortened week kicked off with one big crisis averted for now. During the long weekend, an agreement was reached between President Biden and House Majority Leader…