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The Latest Breaking News from FDA

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

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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

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

MarketBeat

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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 Conversation

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

The Guardian - US

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…

Roll Call

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.

Reason

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

MarketBeat

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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…

Reason

What Do Bruen, Dobbs, and SFFA Have In Common?

The Supreme Court issued landmark rulings that were resisted by lower courts, and the Supreme Court refused to intervene.

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MarketBeat

Eton Pharmaceuticals Q1 Earnings Call Highlights

Eton Pharmaceuticals (NASDAQ:ETON) raised its 2026 revenue outlook after reporting record first-quarter product sales and highlighting early progress from two recent product launches, DESMODA and HEMANGEOL. Chief Executive Officer Sean Brynjelsen said the company now expects full-year revenue to ex

MarketBeat

CapsoVision Q1 Earnings Call Highlights

CapsoVision (NASDAQ:CV) reported steady first-quarter revenue and said it continues to advance artificial intelligence and capsule endoscopy programs aimed at expanding the use of its gastrointestinal imaging platform. On the company’s first-quarter 2026 earnings call, President and Chief Executive

MarketBeat

Celcuity Q1 Earnings Call Highlights

Celcuity (NASDAQ:CELC) reported a wider first-quarter loss as the biotechnology company increased spending tied to commercial launch preparations and continued development of gedatolisib, its investigational therapy for hormone receptor-positive, HER2-negative advanced breast cancer. On the company

Axios

Supreme Court allows abortion pill access while lawsuit proceeds

The widely expected order provides legal certainty for pharmacies, telehealth companies and clinicians.

The Independent UK

Supreme Court preserves access to abortion drug mifepristone while legal battle continues

Justices block nationwide ban on mail-order and telehealth access to widely used abortion pill while high-profile legal challenge continues

The Guardian - US

Supreme court allows abortion pill mifepristone to continue to be available by mail

Louisiana had sued the FDA in a bid to curtail the regulatory agency’s rules on prescribing mifepristone remotely

MarketBeat

Bicara Therapeutics Touts Cancer Drug Progress Ahead of 2026 Pivotal Data

Bicara Therapeutics (NASDAQ:BCAX) said its lead cancer drug candidate, ficerafusp alfa, remains on track for pivotal data in head and neck cancer in mid-2026, as the company outlined its development strategy and competitive positioning at the Bank of America Healthcare Conference. Ryan Kohlhepp of

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