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FDA

Here's what RFK Jr., FDA got wrong about menopausal hormone therapy Medpage Today13:22Hormone Replacement Therapy Menopause Reproductive Health

FDA removes black box warning from menopause hormone therapies Feminist Majority Foundation11:39Hormone Replacement Therapy Menopause Reproductive Health

ByHeart recalls infant formula batches amid FDA botulism investigation KVLY-TV07:22Baby Formula

FDA closes investigation into Listeria outbreak; continues work on infant botulism outbreak Food Safety News00:13Baby Formula

FDA’s revolving door reveals Pazdur as new CDER head Pharmaceutical Technology09:07Pharma Health Business (US)

FDA appoints veteran Pazdur to replace Tidmarsh pharmaphorum05:21Pharma Health Business (US)

Withings' FDA-cleared smart thermometer does more than take your temp - what's new ZDNet09:08FDA-cleared Pharma BeamO

BeamO ‘thermometer of the future' is now FDA-Cleared and available in the US CNET05:47FDA-cleared Pharma BeamO

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths MailOnline15:22Sarepta Therapeutics Biology Pharma

Sarepta shares jump after FDA approves updated Elevidys label Benzinga18:08Sarepta Therapeutics Biology Pharma

Kura scores FDA okay for rival to Syndax's leukaemia drug pharmaphorum07:02Kura Leukaemia Pharma

Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy Pharmaceutical Technology07:01Kura Leukaemia Pharma

FDA recalls commonly prescribed ADHD medication over failed lab tests Post-Standard, New York17:36ADHD Pharma New York

Nationwide recall issued for ADHD medication taken by millions... FDA warns of 'adverse health… MailOnline11:14ADHD Pharma New York

FDA seeks guidance from the Digital Health Advisory Committee on AI: Considerations for innovators of digital mental… JD Supra14:38Health AI IT

FDA’s Digital Health Advisory Committee considers generative AI therapy chatbots for depression JD Supra12:06Health AI IT

FDA seeks to accelerate biosimilar development by easing data requirements JD Supra11:05Pharma Global Health

US FDA eased biosimilar regulations, raising pharma industry’s hopes for lower drug prices, larger access Korea Biomedical Review21:45Pharma Global Health

Senator Marshall introduces GRAS reform bill JD Supra13:08Roger Marshall Kansas Senate FEMA

Congress is writing GRAS law faster than the FDA can keep up Food Safety News00:09Roger Marshall Kansas Senate FEMA

Latest News

In the last half-hour

Trump's FDA head fighting to retain power as infighting roils agency: report The Raw Story10:40

In the last 2 hours

Government Shutdown Ends — USDA Funding and Farm Bill Extension Farmers Need to Know Successful Farming10:05

In the last 4 hours

Withings' FDA-cleared smart thermometer does more than take your temp - what's new ZDNet09:08

Maxx Orthopedics announces FDA 510(k) clearance for Freedom® Metaphyseal Cone System PRWeb (Press Release)09:06

Dr. Marty Makary Discusses Recent FDA Actions C-Span (Video)09:04

In the last 6 hours

Taiwan finds tainted eggs sold by farm after imposition of transport ban Taiwan News06:26

Disc Medicine (IRON): Valuation Insights Following FDA Priority Review and New Clinical Trial Launch Simply Wall St05:53

BeamO ‘Thermometer of the Future' Is Now FDA-Cleared and Available in the US CNET05:47

In the last 8 hours

FDA Accepts Ascelia Pharma’s Orviglance NDA for Review TipRanks04:35

Earlier today

FDA Announces “plausible Mechanism” Approval Pathway for Certain Personalized Therapies, With Few Details JD Supra02:22

Yesterday

Alembic Pharma gets US FDA approval for angina treatment drug Diltiazem The Business Standard23:45 14-Nov-25

DeLauro Demands Inspection Records for ByHeart Infant Formula Facilities Congresswoman Rosa DeLauro (Press Release)23:03 14-Nov-25

Government funding bill cuts food safety regulations. See the provisions for yourself Snopes.com21:33 14-Nov-25

Introducing SENO - FDA-Compliant Nicotine Films to Redefine $4B Market PRWeb (Press Release)20:02 14-Nov-25

FDA Commissioner Dr. Marty Makary: We've never had this 'essential' conversation on health Fox News18:50 14-Nov-25

Infant formula recall exposes gaps in food safety oversight FoodNavigator.com (USA)18:50 14-Nov-25

Sarepta Shares Jump After FDA Approves Updated Elevidys Label Benzinga18:08 14-Nov-25

Gene Therapy Gets FDA's Strongest Warning After Fatal Liver Injuries Medpage Today17:42 14-Nov-25

The Proliferation of Fake Botox in the United States Draws Increased Federal Scrutiny JD Supra17:01 14-Nov-25

FDA clears Withings Beamo, ‘thermometer of the future’ BioWorld16:59 14-Nov-25

Entera Bio Reports Q3 2025 Results and FDA Agreement TipRanks16:42 14-Nov-25

BrainStorm Cell Therapeutics Announces Third Quarter 2025 Financial Results and Provides… PR Newswire (Press Release)16:31 14-Nov-25

“The Immunotherapy Miracle! Victory in the War on Cancer” by Author, Lynne… WebWire16:27 14-Nov-25

Enveric Biosciences Reports Third Quarter 2025 Financial and Corporate Results Business Wire (Press Release)16:12 14-Nov-25

FDA restricts Sarepta's gene therapy Elevidys after Duchenne patient deaths FiercePharma15:26 14-Nov-25

FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths MailOnline15:22 14-Nov-25

Sarepta Announces FDA’s Approval of Updated Elevidys Prescribing Information Business Wire (Press Release)14:56 14-Nov-25

FDA Issues Warning to Over a Dozen Companies Selling Counterfeit Botox — Including Several in the U.S. People14:53 14-Nov-25

FDA Seeks Guidance from the Digital Health Advisory Committee on AI: Considerations for Innovators of Digital Mental… JD Supra14:38 14-Nov-25

Cases jump to 23 in the botulism outbreak tied to baby formula. Here’s what to know. Boston Globe14:37 14-Nov-25

New FDA Director Could Sway Biotech ETFs ETF Trends14:34 14-Nov-25

FDA Announces Recall of More Greens Powders Linked to Ongoing Salmonella Outbreak Health Magazine14:11 14-Nov-25

HeartBeam (NASDAQ: BEAT) Reports Q3 2025 Results as FDA Review Nears Completion and Commercial… TipRanks14:09 14-Nov-25

FDA Ends Estrogen Black Box Warning—a Move That Could Transform Menopause Care Forever The Tribune, California13:48 14-Nov-25

Dr. Reddy’s, Divis’ units conclude U.S. FDA inspection sans observations The Hindu11:52 14-Nov-25

Formulations unit of Aurobindo Pharma arm gets 9 U.S. FDA observations The Hindu11:41 14-Nov-25

Organon and Henlius' Poherdy, first biosimilar to Roche's Perjeta, scores FDA nod FiercePharma11:02 14-Nov-25

New Drug For The Body’s Powerplant Improves Mitochondrial Function Forbes10:06 14-Nov-25

Can NTLA Stock Bounce Back in 2026 After Recent Pipeline Setbacks? Zacks10:04 14-Nov-25

SRRK Earnings: Scholar Rock Stock Soars on FDA Meeting Despite Q3 Miss TipRanks09:44 14-Nov-25

BodyLogicMD Supports FDA Removal of Black Box Warning for Estrogen Menopause Treatment PR Newswire (Press Release)09:35 14-Nov-25

TEM Continues to Strengthen Its Genomics Leadership With New Products Zacks09:03 14-Nov-25

Alert: Supplements Recalled Over Salmonella Prevention.com08:42 14-Nov-25

Zimmer Biomet Announces FDA Clearance For Enhanced Version Of Rosa Knee System RTT News08:07 14-Nov-25

Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology PR Newswire (Press Release)07:31 14-Nov-25

Scholar Rock Holds Constructive FDA Meeting for Apitegromab TipRanks07:31 14-Nov-25

Omeros Awaits FDA Decision On Lead Drug Candidate Narsoplimab Next Month RTT News07:17 14-Nov-25

Kura scores FDA okay for rival to Syndax's leukaemia drug pharmaphorum07:02 14-Nov-25

Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy Pharmaceutical Technology07:01 14-Nov-25

TuHURA Biosciences, Inc. Reports Third Quarter 2025 Financial Results and Provides a Corporate… PR Newswire (Press Release)07:01 14-Nov-25

Scholar Rock Reports Third Quarter 2025 Financial Results and Recent Business Highlights Business Wire (Press Release)07:00 14-Nov-25

enVVeno Medical Faces FDA Setback on VenoValve TipRanks06:40 14-Nov-25

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design JD Supra06:36 14-Nov-25

Press Release: ACAAI: Sanofi and Regeneron’s Dupixent pivotal study met all primary and secondary endpoints, reducing… Sanofi (Press Release)06:35 14-Nov-25

People’s Pharmacy: Will we ever see action on prescription drug ads? The Tribune, California06:10 14-Nov-25

How Vertex’s Kidney Drug Breakthrough and FDA Recognition Will Impact VRTX Investors Simply Wall St05:36 14-Nov-25

FDA grants label expansion for BrainsWay Deep TMS to treat MDD Verdict Medical Devices05:21 14-Nov-25

Guest Post – Radical Transparency and Product Liability Exposure – The New Frontier Drug & Device Law05:07 14-Nov-25

FDA's plan to boost cheaper copycat drugs could stall at patent office CBS News05:03 14-Nov-25

Shanghai Henlius Biotech’s HLX11 Receives FDA Approval for Breast Cancer Treatment TipRanks04:17 14-Nov-25

FDA Accepts Outlook Therapeutics' Resubmitted Bla For Ons-5010 In Wet AMD, Decision Due In December RTT News04:04 14-Nov-25

Amneal Secures FDA Approval For First Generic Version Of Omnipaque Injection RTT News03:54 14-Nov-25

FDA Accepts Outlook Therapeutics' Resubmitted Bla For Ons-5010 In Wet AMD, Decision Due This Month RTT News03:34 14-Nov-25

FDA Leadership Outlines “Plausible Mechanism” Pathway for Bespoke Therapies JD Supra02:42 14-Nov-25

FDA closes investigation into Listeria outbreak; continues work on infant botulism outbreak Food Safety News00:13 14-Nov-25

In the last 7 days

PepsiCo Recalls Popular 'Diet' Drink for Containing 25 Grams of Sugar Health Magazine23:37 13-Nov-25

Grace Therapeutics Reports Q2 2026 Results and FDA Progress TipRanks23:31 13-Nov-25

Local doctor reacts to new FDA black box removal on hormone replacement therapy WDAM18:30 13-Nov-25

Nyxoah Announces Q3 2025 Results and FDA Approval for Genio System TipRanks17:44 13-Nov-25

FDA staff argue AI hallucinations can be minimized, but only at a cost BioWorld17:35 13-Nov-25

FDA Quietly Approves Denosumab Biosimilars, Issues Interchangeability for Others Center for Biosimilars17:32 13-Nov-25

Outlook Therapeutics’ FDA Review for ONS-5010 Resubmission TipRanks17:03 13-Nov-25

Kura Oncology Gains FDA Approval for KOMZIFTITM TipRanks16:53 13-Nov-25

Key HER2-Positive Breast Cancer Therapy Gets Its First Biosimilar Medpage Today16:35 13-Nov-25

Stereotaxis’ GenesisX Robotic Magnetic Navigation system receives U.S. FDA clearance Robotics 24/716:29 13-Nov-25

FDA to Allocate $200M Toward Combating Illicit Vapes Tobacco Reporter Magazine16:22 13-Nov-25

CytoSorbents Reports Third Quarter 2025 Financial Results and Provides Business Update PR Newswire (Press Release)16:09 13-Nov-25

HeartBeam Reports Third Quarter 2025 Results Business Wire (Press Release)16:03 13-Nov-25

FDA clears Kura/Kyowa’s Komzifti in r/r NPM1 mutant AML BioWorld15:34 13-Nov-25

STXS Secures FDA Approval for GenesisX to Broaden Surgical Robotics Zacks15:03 13-Nov-25

Cytokinetics Gains 11.4% in a Week: Is There More Room for Growth? Zacks14:53 13-Nov-25

Two Drugs Approved for NPM1-Mutated Leukemia Medpage Today14:23 13-Nov-25

NavJam LLC Announces Exclusive Global Distribution Partnership with Ruthless Spine Business Wire (Press Release)13:56 13-Nov-25

FDA Approves Caplyta for Major Depressive Disorder in Adults HealthDay13:56 13-Nov-25

FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma HealthDay13:46 13-Nov-25

Two drugs that treat prostate cancer may also be effective against leukemia Penn State News13:29 13-Nov-25

Here's What RFK Jr., FDA Got Wrong About Menopausal Hormone Therapy Medpage Today13:22 13-Nov-25

A Look at UCB (ENXTBR:UCB) Valuation Following FDA Approval of KYGEVVI for TK2d Simply Wall St13:19 13-Nov-25

Applied Therapeutics Tanks As FDA Path For Lead Rare-Disease Drug Turns Uncertain Benzinga13:17 13-Nov-25

Oncology injectable facility of Zydus gets two U.S. FDA observations The Hindu12:49 13-Nov-25

Kyowa's bet on Kura pays off as partners' oral med for AML subset wins FDA approval FiercePharma12:08 13-Nov-25

Withings' smart thermometer is FDA-cleared - and checks more than your temperature ZDNet12:01 13-Nov-25

FDA Removes Black Box Warning from Menopause Hormone Therapies Feminist Majority Foundation11:39 13-Nov-25

STAT Plus: Kura Oncology secures approval for leukemia drug, its first STAT11:39 13-Nov-25

Captiva Spine announces FDA clearance for Flat-Panel C-Arm Calibrators and AI-Assisted… PRWeb (Press Release)11:38 13-Nov-25

FDA Seeks to Accelerate Biosimilar Development by Easing Data Requirements JD Supra11:05 13-Nov-25

US approves four Indonesian labs for shrimp safety testing Antara News10:54 13-Nov-25

Rapid Nexus Becomes the First Company to Receive FDA Clearance for its Advanced Wound-Healing… PR Newswire (Press Release)10:42 13-Nov-25

Ingenus Pharmaceuticals Announces FDA Approval and Launch of First and Only Generic Equivalent… PR Newswire (Press Release)10:20 13-Nov-25

Lords Committee report highlights lack of evidence behind civil service 60% office working mandate The FDA Trade Union (Press Release)09:59 13-Nov-25

Clairity Raises $43 Million in Series B to Launch First FDA-Authorized AI Platform for Breast… Business Wire (Press Release)09:52 13-Nov-25

Dr. Richard Pazdur Appointed to Lead FDA’s Drug Division After Turbulent Year HealthDay09:41 13-Nov-25

Orchestra BioMed Secures FDA Breakthrough Designation TipRanks09:14 13-Nov-25

Should You Buy the Dip in Intellia Therapeutics Stock? Barchart09:10 13-Nov-25

Telix Pharmaceuticals Limited (TLX) Faces Securities Class Action Amid SEC Subpoena, Complete… Business Wire (Press Release)09:00 13-Nov-25

Tharimmune Receives Positive FDA Feedback for TH104 Prophylaxis Program Against Respiratory… PR Newswire (Press Release)08:06 13-Nov-25

Withings Redefines At-Home Family Healthcare in the US with FDA Clearance of BeamO PR Newswire (Press Release)08:03 13-Nov-25

FDA clears ViTAA Medical’s AI aortic surgery planning tool Verdict Medical Devices07:58 13-Nov-25

Venus Concept Gains FDA Clearance for Venus Nova TipRanks07:32 13-Nov-25

ByHeart recalls infant formula batches amid FDA botulism investigation KVLY-TV07:22 13-Nov-25

FDA Signals Major Shift for QMSR Transition for Medical Device Applications JD Supra07:09 13-Nov-25

FDA unveils new pathway to usher bespoke therapies to market Pharmaceutical Technology07:07 13-Nov-25

icotec Receives FDA Clearance for the CMORE® CT System, Expanding its BlackArmor® Engineered… PR Newswire (Press Release)07:01 13-Nov-25

BrainsWay Gains FDA Approval for Adolescent Depression Treatment TipRanks06:41 13-Nov-25

Innate Pharma’s Q3 2025 Update: FDA Clears Phase 3 Trial for Lacutamab TipRanks06:41 13-Nov-25

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15 Nov 10:40

FDA News

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