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The Latest Breaking News from FDA

MAGA runs on ZYN: Nicotine pouches become all the rage with Trump admin including the health secretary RFK Jr

Kennedy has publicly endorsed the popular product, calling it ‘probably the safest way to consume nicotine’

The Independent UK

‘Desire Doesn’t Expire’: The Pink Pill Addyi Now Approved for Women up to 65 — What to Know About the New Approval

For years, many women entering menopause or postmenopause were told that declining sexual desire was simply part of aging. Now, a major FDA decision is changing that conversation after Addyi, often called the “pink pill,” received expanded approval for women under 65, including postmenopausal women. The drug, known generically as…

Budget and the Bees

NRx Pharmaceuticals Q1 Earnings Call Highlights

NRx Pharmaceuticals (NASDAQ:NRXP) said it advanced several regulatory, manufacturing and clinical initiatives during the first quarter of 2026, including progress toward potential approval of its preservative-free ketamine product, KETAFREE, and preparations for an NDA filing for NRX-100. Founder,

MarketBeat

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Gossamer Bio Q1 Earnings Call Highlights

Gossamer Bio (NASDAQ:GOSS) said it is moving ahead with plans to seek U.S. approval for seralutinib in pulmonary arterial hypertension, outlining a September 2026 target for a New Drug Application submission while also detailing new imaging data and steps to address its balance sheet during its firs

MarketBeat

Flavored vapes led to a major shake-up at the FDA – 3 health policy analysts explain the science behind the controversial products

The resignation of Marty Makary, commissioner of the U.S. Food and Drug Administration, on May 12, 2026, brought to the forefront a heated controversy over fruit-flavored nicotine vapes.

The Conversation

iRhythm Technologies Touts Medicare Win, Zio Growth and AI-Driven Margin Gains

iRhythm Technologies (NASDAQ:IRTC) executives said the company is seeing continued business momentum after a favorable Medicare coverage update, a stronger-than-expected first quarter and progress on several product and margin initiatives. Speaking at an investor event, Stephanie Zhadkevich, senior

MarketBeat

Incyte CEO Says Post-Jakafi Growth Path Is Clearer as Pipeline Catalysts Build

Incyte (NASDAQ:INCY) President and CEO Bill Meury said the company’s post-Jakafi growth profile has become “much clearer” over the past year, pointing to continued growth in its commercial business, late-stage pipeline activity and potential launches across oncology and immunology. Speaking at the

MarketBeat

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Doctors explain why maggot therapy is still a leading treatment in the US

The FDA approved medical use of ‘nature’s microsurgeons’ more than 20 years ago

The Independent UK

GRAIL Says Galleri Demand Is Rising as NHS Talks, FDA Review Move Ahead

GRAIL (NASDAQ:GRAL) said demand for its Galleri multi-cancer early detection test has continued to grow despite recent headlines related to its NHS study, according to comments made by Aaron, who identified himself during the discussion as the company’s CFO, at a Bank of America event. Aaron said t

MarketBeat

Erasca Touts 'Eye-Popping' ERAS-0015 Lung Cancer Data, FDA Path at BofA Conference

Erasca (NASDAQ:ERAS) executives said the company sees multiple potential development paths for its RAS-targeting portfolio, highlighting early clinical activity for ERAS-0015 in lung, pancreatic and colorectal cancers during a Bank of America biotech conference session. Jonathan Lim, Erasca’s chair

MarketBeat

FDA drug center head fired after commissioner's exit, replaced by Davis

The U.S. Food and Drug Administration's drug center sees a leadership change as acting head Tracy Beth Hoeg departs, replaced by deputy Michael Davis. This follows Commissioner Marty Makary's exit amid agency-wide shifts. Karim Mikhail now leads the biologics center, and Lowell Zeta is acting chief of staff. Hoeg's tenure…

The Economic Times

Straus Creamery Ice Cream Recall: Organic Frozen Treat Pulled in 17 States Over Possible Metal Contamination

Straus Family Creamery has recalled selected organic ice cream flavours in 17 US states over fears of metal contamination, although no injuries have been reported.

International Business Times UK

FDA official who scrutinized COVID shots and antidepressants is out in latest shake-up

The Food and Drug Administration's top drug official is stepping down in the latest shake-up at the powerful health agency

The Independent UK

FDA turmoil deepens as top drug chief departs claiming she was fired

Dr Tracy Beth Høeg, the Food and Drug Administration’s top drug regulator, says she was fired from agency after declining to resign

The Guardian - US

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MarketBeat

Stereotaxis Q1 Earnings Call Highlights

Stereotaxis (NYSEAMERICAN:STXS) said its first-quarter results did not yet reflect what management described as a major commercial transition driven by new regulatory approvals, new catheter products and the launch of its GenesisX robotic system. Chairman and CEO David Fischel told investors that t

The Conversation

Supreme Court preserves access to mifepristone via telehealth – at least for now

The U.S. Supreme Court has decided that patients can continue to get mifepristone, one of the two drugs used for medication abortion, via telehealth and by mail. At least for now.

The Conversation

Sweeteners and the quest for the perfect alternative to sugar

Designing a series of sweetener trials seemed straightforward enough to us as behavioural scientists who specialise in human appetite and obesity. The plan was simple: replace the added sugar in a range of foods with different classes of alternative sweeteners, holding everything else constant.

The Guardian - US

Seth Meyers on Trump sucking up to Xi: ‘What happened to standing up to China?’

Late-night hosts poked fun at the US president’s fawning China trip in which he said it was an ‘honor’ to be Xi’s friend

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Roll Call

As RFK’s lifestyle seeps into policy, some fret over long-term effect

When Health and Human Services Secretary Robert F. Kennedy Jr. took the helm of the department in February 2025, he pledged to remove special interests from HHS and chart a new path focused on “gold-standard science.” He made his core policy interests clear in November 2024, even before he was President…

Reason

Supreme Court "Shadow Docket" Order Preserves Mifepristone Via Telemedicine--For Now

The Court stayed a lower court order that would have blocked FDA rules allowing the prescription of mifepristone to terminate pregnancies via telemedicine.

MarketBeat

ReposiTrak Q3 Earnings Call Highlights

ReposiTrak (NYSE:TRAK) reported essentially flat fiscal third-quarter revenue while highlighting stronger profitability, continued cash generation and new strategic initiatives tied to food traceability, artificial intelligence and in-store execution. On the company’s fiscal third-quarter 2026 conf

MarketBeat

Takeda Pharmaceutical Q4 Earnings Call Highlights

Takeda Pharmaceutical (NYSE:TAK) reported fiscal 2025 results that management described as solid despite pressure from generic competition to VYVANSE, while outlining a transition plan built around three expected product launches and a broader cost transformation program. The earnings call also mar

Reason

The FDA's New Psychedelic Rules Are Groovy, but the Agency Is Still a Bad Trip

The new rules will fast track clinical testing, but a far cry from legalization or decriminalization.

MarketBeat

CG Oncology BLA Filing on Track as Key Bladder Cancer Data Nears

CG Oncology (NASDAQ:CGON) executives said the company remains on track to complete a rolling biologics license application for cretostimogene in BCG-unresponsive high-risk non-muscle invasive bladder cancer by the fourth quarter, while reiterating expectations for top-line data from a separate Phase

Roll Call

Supreme Court preserves telemedicine access to abortion drug

The Supreme Court on Thursday allowed access to medication abortion via telemedicine and by mail to continue, blocking a decision at the appellate court level that had restricted the drug. The justices granted emergency requests from the makers of mifepristone, Danco Laboratories LLC and GenBioPro Inc., after the New Orleans-based…

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