FDA

Here's what RFK Jr., FDA got wrong about menopausal hormone therapy Medpage Today18:22Hormone Replacement Therapy Menopause Reproductive Health

FDA removes black box warning from menopause hormone therapies Feminist Majority Foundation16:39Hormone Replacement Therapy Menopause Reproductive Health

ByHeart recalls infant formula batches amid FDA botulism investigation KVLY-TV12:22

Baby formula ByHeart linked to botulism outbreak, FDA's investigation continues WXYZ TV, Detroit01:14

FDA’s revolving door reveals Pazdur as new CDER head Pharmaceutical Technology14:07Pazdur Pharma

FDA appoints veteran Pazdur to replace Tidmarsh pharmaphorum10:21Pazdur Pharma

Kura scores FDA okay for rival to Syndax's leukaemia drug pharmaphorum12:02Kura Leukaemia Pharma

Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy Pharmaceutical Technology12:01Kura Leukaemia Pharma

FDA recalls commonly prescribed ADHD medication over failed lab tests Post-Standard, New York22:36ADHD Pharma New York

Nationwide recall issued for ADHD medication taken by millions... FDA warns of 'adverse health… MailOnline16:14ADHD Pharma New York

FDA seeks to accelerate biosimilar development by easing data requirements JD Supra16:05Pharma Global Health

New FDA guidance could speed biosimilar approvals and cut costs National Law Review21:54Pharma Global Health

Senator Marshall introduces GRAS reform bill JD Supra18:08Roger Marshall Kansas Senate FEMA

Congress is writing GRAS law faster than the FDA can keep up Food Safety News05:09Roger Marshall Kansas Senate FEMA

Granules Life Sciences secures first U.S. FDA approval The Hindu09:17U.S. FDA India

Granules India's Hyderabad-based facility gets first U.S. FDA approval The Business Standard07:01U.S. FDA India

DexCom faces new reports of deaths linked to G7 glucose monitor Benzinga18:13

Johnson & Jonson secures FDA approval for multiple myeloma treatment PMLiVE12:06Blood Cancer Johnson and Johnson Cancer Treatment

FDA clears Johnson & Johnson's Darzalex Faspro, enabling early intervention in myeloma progression Benzinga18:02Blood Cancer Johnson and Johnson Cancer Treatment

Latest News

In the last hour

Dr. Reddy’s, Divis’ units conclude U.S. FDA inspection sans observations The Hindu16:52

Formulations unit of Aurobindo Pharma arm gets 9 U.S. FDA observations The Hindu16:41

In the last 2 hours

Organon and Henlius' Poherdy, first biosimilar to Roche's Perjeta, scores FDA nod FiercePharma16:02

In the last 4 hours

New Drug For The Body’s Powerplant Improves Mitochondrial Function Forbes15:06

Can NTLA Stock Bounce Back in 2026 After Recent Pipeline Setbacks? Zacks15:04

SRRK Earnings: Scholar Rock Stock Soars on FDA Meeting Despite Q3 Miss TipRanks14:44

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

TEM Continues to Strengthen Its Genomics Leadership With New Products Zacks14:03

Alert: Supplements Recalled Over Salmonella Prevention.com13:42

In the last 6 hours

Zimmer Biomet Announces FDA Clearance For Enhanced Version Of Rosa Knee System RTT News13:07

Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA® Knee Robotic Technology PR Newswire (Press Release)12:31

Scholar Rock Holds Constructive FDA Meeting for Apitegromab TipRanks12:31

Omeros Awaits FDA Decision On Lead Drug Candidate Narsoplimab Next Month RTT News12:17

Kura scores FDA okay for rival to Syndax's leukaemia drug pharmaphorum12:02

Kura and Kyowa Kirin secure FDA go-ahead for targeted leukaemia therapy Pharmaceutical Technology12:01

TuHURA Biosciences, Inc. Reports Third Quarter 2025 Financial Results and Provides a Corporate… PR Newswire (Press Release)12:01

Scholar Rock Reports Third Quarter 2025 Financial Results and Recent Business Highlights Business Wire (Press Release)12:00

enVVeno Medical Faces FDA Setback on VenoValve TipRanks11:40

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design JD Supra11:36

Press Release: ACAAI: Sanofi and Regeneron’s Dupixent pivotal study met all primary and secondary endpoints, reducing… Sanofi (Press Release)11:35

In the last 8 hours

People’s Pharmacy: Will we ever see action on prescription drug ads? The Tribune, California11:10

How Vertex’s Kidney Drug Breakthrough and FDA Recognition Will Impact VRTX Investors Simply Wall St10:36

FDA grants label expansion for BrainsWay Deep TMS to treat MDD Verdict Medical Devices10:21

Guest Post – Radical Transparency and Product Liability Exposure – The New Frontier Drug & Device Law10:07

FDA's plan to boost cheaper copycat drugs could stall at patent office CBS News10:03

Earlier today

Shanghai Henlius Biotech’s HLX11 Receives FDA Approval for Breast Cancer Treatment TipRanks09:17

FDA Accepts Outlook Therapeutics' Resubmitted Bla For Ons-5010 In Wet AMD, Decision Due In December RTT News09:04

Amneal Secures FDA Approval For First Generic Version Of Omnipaque Injection RTT News08:54

FDA Accepts Outlook Therapeutics' Resubmitted Bla For Ons-5010 In Wet AMD, Decision Due This Month RTT News08:34

FDA Leadership Outlines “Plausible Mechanism” Pathway for Bespoke Therapies JD Supra07:42

FDA closes investigation into Listeria outbreak; continues work on infant botulism outbreak Food Safety News05:13

PepsiCo Recalls Popular 'Diet' Drink for Containing 25 Grams of Sugar Health Magazine04:37

Grace Therapeutics Reports Q2 2026 Results and FDA Progress TipRanks04:31

Yesterday

Local doctor reacts to new FDA black box removal on hormone replacement therapy WDAM23:30 13-Nov-25

Nyxoah Announces Q3 2025 Results and FDA Approval for Genio System TipRanks22:44 13-Nov-25

FDA staff argue AI hallucinations can be minimized, but only at a cost BioWorld22:35 13-Nov-25

FDA Quietly Approves Denosumab Biosimilars, Issues Interchangeability for Others Center for Biosimilars22:32 13-Nov-25

Outlook Therapeutics’ FDA Review for ONS-5010 Resubmission TipRanks22:03 13-Nov-25

Kura Oncology Gains FDA Approval for KOMZIFTITM TipRanks21:53 13-Nov-25

Key HER2-Positive Breast Cancer Therapy Gets Its First Biosimilar Medpage Today21:35 13-Nov-25

Stereotaxis’ GenesisX Robotic Magnetic Navigation system receives U.S. FDA clearance Robotics 24/721:29 13-Nov-25

FDA to Allocate $200M Toward Combating Illicit Vapes Tobacco Reporter Magazine21:22 13-Nov-25

CytoSorbents Reports Third Quarter 2025 Financial Results and Provides Business Update PR Newswire (Press Release)21:09 13-Nov-25

HeartBeam Reports Third Quarter 2025 Results Business Wire (Press Release)21:03 13-Nov-25

FDA clears Kura/Kyowa’s Komzifti in r/r NPM1 mutant AML BioWorld20:34 13-Nov-25

STXS Secures FDA Approval for GenesisX to Broaden Surgical Robotics Zacks20:03 13-Nov-25

Cytokinetics Gains 11.4% in a Week: Is There More Room for Growth? Zacks19:53 13-Nov-25

Two Drugs Approved for NPM1-Mutated Leukemia Medpage Today19:23 13-Nov-25

NavJam LLC Announces Exclusive Global Distribution Partnership with Ruthless Spine Business Wire (Press Release)18:56 13-Nov-25

FDA Approves Caplyta for Major Depressive Disorder in Adults HealthDay18:56 13-Nov-25

FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma HealthDay18:46 13-Nov-25

Two drugs that treat prostate cancer may also be effective against leukemia Penn State News18:29 13-Nov-25

Here's What RFK Jr., FDA Got Wrong About Menopausal Hormone Therapy Medpage Today18:22 13-Nov-25

A Look at UCB (ENXTBR:UCB) Valuation Following FDA Approval of KYGEVVI for TK2d Simply Wall St18:19 13-Nov-25

Applied Therapeutics Tanks As FDA Path For Lead Rare-Disease Drug Turns Uncertain Benzinga18:17 13-Nov-25

Oncology injectable facility of Zydus gets two U.S. FDA observations The Hindu17:49 13-Nov-25

Kyowa's bet on Kura pays off as partners' oral med for AML subset wins FDA approval FiercePharma17:08 13-Nov-25

Withings' smart thermometer is FDA-cleared - and checks more than your temperature ZDNet17:01 13-Nov-25

FDA Removes Black Box Warning from Menopause Hormone Therapies Feminist Majority Foundation16:39 13-Nov-25

STAT Plus: Kura Oncology secures approval for leukemia drug, its first STAT16:39 13-Nov-25

Captiva Spine announces FDA clearance for Flat-Panel C-Arm Calibrators and AI-Assisted… PRWeb (Press Release)16:38 13-Nov-25

FDA Seeks to Accelerate Biosimilar Development by Easing Data Requirements JD Supra16:05 13-Nov-25

US approves four Indonesian labs for shrimp safety testing Antara News15:54 13-Nov-25

Rapid Nexus Becomes the First Company to Receive FDA Clearance for its Advanced Wound-Healing… PR Newswire (Press Release)15:42 13-Nov-25

Ingenus Pharmaceuticals Announces FDA Approval and Launch of First and Only Generic Equivalent… PR Newswire (Press Release)15:20 13-Nov-25

Lords Committee report highlights lack of evidence behind civil service 60% office working mandate The FDA Trade Union (Press Release)14:59 13-Nov-25

Clairity Raises $43 Million in Series B to Launch First FDA-Authorized AI Platform for Breast… Business Wire (Press Release)14:52 13-Nov-25

Dr. Richard Pazdur Appointed to Lead FDA’s Drug Division After Turbulent Year HealthDay14:41 13-Nov-25

Orchestra BioMed Secures FDA Breakthrough Designation TipRanks14:14 13-Nov-25

Should You Buy the Dip in Intellia Therapeutics Stock? Barchart14:10 13-Nov-25

Telix Pharmaceuticals Limited (TLX) Faces Securities Class Action Amid SEC Subpoena, Complete… Business Wire (Press Release)14:00 13-Nov-25

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

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

FDA clears ViTAA Medical’s AI aortic surgery planning tool Verdict Medical Devices12:58 13-Nov-25

Venus Concept Gains FDA Clearance for Venus Nova TipRanks12:32 13-Nov-25

ByHeart recalls infant formula batches amid FDA botulism investigation KVLY-TV12:22 13-Nov-25

FDA Signals Major Shift for QMSR Transition for Medical Device Applications JD Supra12:09 13-Nov-25

FDA unveils new pathway to usher bespoke therapies to market Pharmaceutical Technology12:07 13-Nov-25

icotec Receives FDA Clearance for the CMORE® CT System, Expanding its BlackArmor® Engineered… PR Newswire (Press Release)12:01 13-Nov-25

BrainsWay Gains FDA Approval for Adolescent Depression Treatment TipRanks11:41 13-Nov-25

Innate Pharma’s Q3 2025 Update: FDA Clears Phase 3 Trial for Lacutamab TipRanks11:41 13-Nov-25

BeamO, the ‘Thermometer of the Future’, Is Now Available in the US and FDA-Cleared CNET11:40 13-Nov-25

FDA recall of blood pressure pills due to cancer-causing contaminant may point to higher... Knowridge Science Report11:07 13-Nov-25

FDA unveils swift route to market for personalised drugs pharmaphorum10:55 13-Nov-25

Time to Chuck Lohr Out The Window and Start Over With Riegel? Drug & Device Law10:10 13-Nov-25

Abortion medications targeted by SC lawmakers at state, federal level The State, South Carolina10:09 13-Nov-25

FDA’s Plan to Speed Drug Reviews Risks Skepticism From Insurers Bloomberg Law10:07 13-Nov-25

FDA clears Augmedics’ AR headset for use with spine surgery system Verdict Medical Devices09:14 13-Nov-25

Avenzo Therapeutics Granted Fast Track Designation For AVZO-1418, A Potential Best-In-Class… Drugs Discovery Online08:22 13-Nov-25

Rfk, Vaccines, and the FDA The Independent Institute (Weblog)07:35 13-Nov-25

FDA Issues Guidance to Industry in Effort to Accelerate Development and Reduce Costs of Biosimilar Drugs JD Supra07:14 13-Nov-25

Senate funding package includes major cuts to food safety programs Food Safety News06:10 13-Nov-25

Island Pharmaceuticals to Host Webinar on FDA Feedback for Galidesivir TipRanks06:04 13-Nov-25

Innate Pharma Reports Third Quarter 2025 Business Update and Financial Results Business Wire (Press Release)06:02 13-Nov-25

Calico Life Sciences Announces U.S. FDA Orphan Drug Designation For Investigational Treatment… Drugs Discovery Online05:50 13-Nov-25

Congress is writing GRAS law faster than the FDA can keep up Food Safety News05:09 13-Nov-25

Artrya Limited Advances U.S. Market Entry with FDA Clearances and Strategic Expansion TipRanks04:12 13-Nov-25

Could a Shift in enGene (ENGN) Trial Endpoints Reveal New Priorities in Its Clinical Strategy? Simply Wall St02:11 13-Nov-25

Baby formula ByHeart linked to botulism outbreak, FDA's investigation continues WXYZ TV, Detroit01:14 13-Nov-25

Dcxm alert: Kirby McInerney LLP Reminds DexCom, Inc. Investors of Important Deadline in Class… Business Wire (Press Release)01:05 13-Nov-25

Anteris posts Q3 2025 results, secures key approvals to launch PARADIGM trial Proactive Investors (Australia)00:10 13-Nov-25

Island Pharmaceuticals Initiates Trading Halt Pending FDA Feedback TipRanks00:07 13-Nov-25

In the last 7 days

FDA recalls commonly prescribed ADHD medication over failed lab tests Post-Standard, New York22:36 12-Nov-25

FDA Unveils New Path for Approving Drugs for Just One Patient Bloomberg Law22:25 12-Nov-25

STAT Plus: FDA chiefs offer roadmap to expand custom gene-editing treatments like Baby KJ’s STAT22:09 12-Nov-25

A Deep Dive into uniQure (QURE) Valuation After FDA Uncertainty Shakes Huntington’s Disease Program Simply Wall St22:07 12-Nov-25

Perimeter Medical Imaging AI Announces Strong Third Quarter 2025 Financial Results PR Newswire (Press Release)22:06 12-Nov-25

Pazdur ‘optimal fit’ to lead FDA’s Cder BioWorld22:03 12-Nov-25

Amended stopgap spending bill includes full 2026 funding for FDA BioWorld22:03 12-Nov-25

FDA unveils new regulatory roadmap for bespoke drug therapies BioPharma Dive22:02 12-Nov-25

Magstim gets FDA nod for chronic pain treatment BioWorld21:33 12-Nov-25

DiaMedica Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business… Business Wire (Press Release)21:32 12-Nov-25

'Most MAGA thing ever': Outrage as another wild provision snuck into shutdown bill The Raw Story20:53 12-Nov-25

More red flags on peptides even as softening of FDA oversight could happen soon under Rfk Jr. The Niche (Weblog)20:43 12-Nov-25

Shutdown Deal Kills Rules to Prevent Food Contamination and Foodborne Illnesses Truthout20:10 12-Nov-25

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14 Nov 16:52

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FDA News

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