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FDA

GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List JD Supra16:43Mounjaro Eli Lilly Pharma

A major GLP-1 Drug shortage is over. Some patients aren’t celebrating WIRED22:29Mounjaro Eli Lilly Pharma

Egg recall upgraded to most severe status by FDA due to salmonella risk and hospitalizations Real Simple19:51

Throw out these recalled vegetables immediately: FDA identifies 7 risky products Staten Island Advance, New York18:47

Roche wins first-line approval for PI3K inhibitor combo in breast cancer Pharmaceutical Technology17:39Breast Cancer Cancer Treatment Cancer

Roche’s Itovebi combination granted FDA approval for advanced breast cancer PMLiVE12:39Breast Cancer Cancer Treatment Cancer

Is it COVID or flu? FDA gives 'Official' authorization to test that will tell you CNET.co.uk06:29Flu Flu Pandemics Covid

FDA authorizes over-the-counter combined COVID-19 and flu test CBS News15:37Flu Flu Pandemics Covid

FDA approves marstacimab-hncq for adults, adolescents with Hemophilia A or b without inhibitors Pharmacy Times22:32Pharma

Marstacimab gets FDA nod for Hemophilia A or b without inhibitors Medpage Today22:28Pharma

FDA approves Imuldosa, a biosimilar to Stelara Center for Biosimilars21:43Stelara Inflammatory Bowel Disease Pharma

FDA approves Imuldosa, a fifth biosimilar to Stelara American Journal of Managed Care21:56Stelara Inflammatory Bowel Disease Pharma

Bob Ferguson asks Spokane judge for swift decision on abortion pill lawsuit against FDA Bellingham Herald03:23Mifepristone Pharma Abortion Rights

Ferguson urges decision on mifepristone lawsuit against FDA The Seattle Times18:30Mifepristone Pharma Abortion Rights

Bakery that makes Sara Lee and Entenmann’s pushes back on FDA sesame warning Twin Cities Pioneer Press19:44Food Packaging and Labelling Food Manufacturers Food & Drink

Bakery that makes Sarah Lee and Entenmann’s pushes back on FDA sesame warning The Columbian, Washington16:43Food Packaging and Labelling Food Manufacturers Food & Drink

FDA AdCom votes in favour of Stealth’s Barth syndrome drug Pharmaceutical Technology19:51Dispute Resolution Pharma Law

Elamipretide for Barth syndrome survives FDA advisory vote Medpage Today14:29Dispute Resolution Pharma Law

EXAS gains FDA nod for Cologuard Plus, progresses with CRC screening Zacks13:35Cologuard Plus Cancer

Exact Sciences' upgraded Cologuard test gets FDA approval Wisconsin State Journal16:38Cologuard Plus Cancer

Latest News

In the last 2 hours

A scoping review on advancements in noninvasive wearable technology for heart failure management Nature.com05:56

FDA steps up import enforcement because of pesticides, heavy metals and more Food Safety News05:12

In the last 4 hours

Springbok Analytics receives FDA 510(k) clearance for MuscleView MobiHealthNews04:23

FDA initiates probe in alleged food poisoning incident at Chinchwad school Hindustan Times03:46

Bob Ferguson asks Spokane judge for swift decision on abortion pill lawsuit against FDA Bellingham Herald03:23

Earlier today

Dem AGs Urge Judge To Rule Now On FDA Abortion Pill Regs Law36000:48

Yesterday

FDA Roundup: Hemophilia B Therapy, Stelara Biosimilar Approval Drug Topics22:52 11-Oct-24

New ms drug approved by FDA NBC 2922:48 11-Oct-24

FDA Approves Marstacimab-hncq for Adults, Adolescents With Hemophilia A or B Without Inhibitors Pharmacy Times22:32 11-Oct-24

Marstacimab Gets FDA Nod for Hemophilia A or B Without Inhibitors Medpage Today22:28 11-Oct-24

FDA Outlines Its Proposed Process for Post-market Assessment of Chemicals in Food JD Supra22:23 11-Oct-24

FDA Approves Imuldosa, a Fifth Biosimilar to Stelara American Journal of Managed Care21:56 11-Oct-24

FDA Approves Imuldosa, a Biosimilar to Stelara Center for Biosimilars21:43 11-Oct-24

Abbott advances clinical studies in pulsed field ablation, collects mapping clearance from FDA FierceBiotech21:39 11-Oct-24

Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months FiercePharma21:35 11-Oct-24

FDA Approves Single-Dose, Intravenous Paclitaxel Biosimilar for Breast Cancer OncLive21:28 11-Oct-24

FDA Roundup: October 11, 2024 U.S. Food and Drug Administration (Press Release)21:26 11-Oct-24

FDA gives early nod to Genentech’s first-line breast cancer drug BioWorld21:21 11-Oct-24

FDA approves first once-weekly drug treatment regimen for hemophilia UPI21:15 11-Oct-24

Nurix Therapeutics Reports Third Quarter Fiscal 2024 Financial Results and Provides a Corporate Update GlobeNewswire (Press Release)21:03 11-Oct-24

FDA Approves First Weekly Subcutaneous Therapy for Hemophilia B Drug Topics20:39 11-Oct-24

South Korean company Dong-A ST wins FDA approval for Stelara biosimilar Pharmaceutical Technology20:31 11-Oct-24

FDA Issues Broad Exemptions from DSCSA Enhanced Drug Distribution Security Requirements JD Supra20:11 11-Oct-24

Pfizer hemophilia drug marstacimab is approved by FDA ENDPOINTS20:04 11-Oct-24

FDA AdCom votes in favour of Stealth’s Barth syndrome drug Pharmaceutical Technology19:51 11-Oct-24

FDA Grants Orphan Drug Designation to LMP744 for Glioma OncLive19:16 11-Oct-24

Pfizer’s Hympavzi Wins FDA Approval to Treat Hemophilia Bloomberg Law19:10 11-Oct-24

FDA Approves Inavolisib in Locally Advanced, Metastatic Breast Cancer American Journal of Managed Care19:03 11-Oct-24

FDA Approves Imuldosa, Biosimilar to Stelara Drug Topics18:46 11-Oct-24

FDA Approves New Treatment for Hemophilia A or B PR Newswire (Press Release)18:36 11-Oct-24

Ferguson urges decision on mifepristone lawsuit against FDA The Seattle Times18:30 11-Oct-24

U.S. FDA Approves Pfizer’s HYMPAVZI™ (marstacimab-hncq) for the Treatment of Adults and… Business Wire (Press Release)18:25 11-Oct-24

February 2, 2026 Is Quickly Approaching—Are You QMSR Ready? JD Supra18:09 11-Oct-24

Roche wins first-line approval for PI3K inhibitor combo in breast cancer Pharmaceutical Technology17:39 11-Oct-24

HeartFlow Announces Favorable Coverage Determination for Plaque Analysis by Four Medicare Administrative Contractors GlobeNewswire (Press Release)17:29 11-Oct-24

Washington State Seeks Order Ending Abortion Pill Regulations Bloomberg Law17:08 11-Oct-24

FDA commissioner will discuss regulations, research, health challenges Cornell Chronicle16:56 11-Oct-24

Testosterone Cypionate vs. Enanthate: How Do They Compare? Very Well Health16:41 11-Oct-24

3D Printing News You Need to Know 3D Printing Industry16:37 11-Oct-24

Ferguson urges federal judge to unravel restrictions on mifepristone Washington State Attorney General (Press Release)16:27 11-Oct-24

Thermo Fisher plant in North Carolina flagged for contamination, air bubble issues in FDA… FiercePharma16:20 11-Oct-24

MedTech Innovation Takes Center Stage at TCT 2024 Newswise (Press Release)15:36 11-Oct-24

FDA pushes for progress in sodium reduction target, aims to cut average intake to 2,750 mg/day FoodNavigator.com (USA)15:11 11-Oct-24

SightMD Leads the Way in iDose Glaucoma Treatment with Dr. Alanna Nattis and Dr. Eric Rosenberg PRWeb (Press Release)15:07 11-Oct-24

FDA Accepts New Drug Application for Elinzanetant to Treat Hot Flashes Associated With Menopause Pharmacy Times14:34 11-Oct-24

Elamipretide for Barth Syndrome Survives FDA Advisory Vote Medpage Today14:29 11-Oct-24

Facing Industry Disruptions, FDA Grants Temporary Exemption From DSCSA Requirements For Trading Partners Pharmacy Times14:14 11-Oct-24

US FDA Approves Dong-A ST’s IMULDOSA™ (ustekinumab-srlf), a Biosimilar to STELARA® Business Wire (Press Release)14:01 11-Oct-24

Volixibat gains FDA breakthrough therapy designation Pharmaceutical Business Review13:52 11-Oct-24

Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting… PR Newswire (Press Release)13:09 11-Oct-24

U.S. Food and Drug Administration Approves FoundationOne®Liquid CDx as a Companion Diagnostic… Business Wire (Press Release)13:07 11-Oct-24

Roche's breast cancer combination therapy Itovebi bags FDA approval Manufacturing Chemist13:01 11-Oct-24

Roche’s Itovebi combination granted FDA approval for advanced breast cancer PMLiVE12:39 11-Oct-24

Cancer Vaccines Market Forecasts from 2024 to 2029: Lung and Breast Cancer Remain Key Targets, FDA Approvals for HPV… GlobeNewswire (Press Release)11:51 11-Oct-24

Natus seeks FDA clearance for new EEG device Verdict Medical Devices10:42 11-Oct-24

Roche gets FDA green light for breast cancer drug Itovebi pharmaphorum10:08 11-Oct-24

Samil Pharmaceutical signs CMO deal with Taiwan’s Formosa for FDA-approved ophthalmic drug Korea Biomedical Review08:02 11-Oct-24

Sandoz US launches generic paclitaxel in single-dose vial, further expanding US oncology portfolio GlobeNewswire (Press Release)06:02 11-Oct-24

FDA approves Roche’s Itovebi, a targeted treatment for advanced hormone receptor-positive, HER2-negative breast cancer… GlobeNewswire (Press Release)06:02 11-Oct-24

RecensMedical's OcuCool,1st Korean medical device to receive FDA De Novo approval Korea Biomedical Review03:45 11-Oct-24

Dong-A ST’s Stelara biosimilar Imuldosa scores FDA approval Korea Biomedical Review02:46 11-Oct-24

A Georgia biotech firm finds itself fighting the FDA and former workers News & Observer, North Carolina00:24 11-Oct-24

In the last 7 days

'Impossible' FDA adcomm ends in favor of Stealth’s ultra-rare disease med FierceBiotech23:38 10-Oct-24

FDA adcomm supports first potential drug for ultra-rare, fatal Barth syndrome ENDPOINTS22:51 10-Oct-24

PI3K Inhibitor Wins FDA Approval for Advanced Breast Cancer Medpage Today22:44 10-Oct-24

The FDA Just Recalled Nearly 10 Million Pounds of Ready-to-Eat Meat and Poultry Nationwide Food & Wine Magazine22:37 10-Oct-24

Roche burnishes breast cancer portfolio with FDA approval for Itovebi, a threat to Novartis and … FiercePharma22:34 10-Oct-24

Natus seeks FDA 510(k) clearance for its highly anticipated point-of-care EEG solution PR Newswire (Press Release)22:05 10-Oct-24

FDA approves Roche's new treatment for subset of breast cancer patients ENDPOINTS22:00 10-Oct-24

FDA Approves Inavolisib With Palbociclib and Fulvestrant for Breast Cancer Pharmacy Times21:45 10-Oct-24

FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive,… Business Wire (Press Release)21:14 10-Oct-24

FDA Approves Inavolisib Plus Palbociclib/Fulvestrant for Endocrine-Resistant, PIK3CA-Mutated, HR+, HER2– Advanced… OncLive21:13 10-Oct-24

Therapixel Announces Two New FDA Clearances for its Most Advanced Breast Cancer Screening AI… PR Newswire (Press Release)20:54 10-Oct-24

Sixty Years Later, and Thalidomide Is Still With Us Scientific American20:39 10-Oct-24

Final FDA electronic systems guidance offers greater compliance flexibility JD Supra20:32 10-Oct-24

Soleno Therapeutics Nears FDA Decision: Strong Buy Targeting PWS Hyperphagia Treatments Seeking Alpha20:23 10-Oct-24

Tirzepatide Shortage Resolved JD Supra20:22 10-Oct-24

FDA upgrades egg recall to Class 1 Salon.com20:07 10-Oct-24

Egg Recall Upgraded to Most Severe Status by FDA Due to Salmonella Risk and Hospitalizations Real Simple19:51 10-Oct-24

Magellan Diagnostics Sentenced for Concealing Malfunction in Lead Testing Devices U.S. Department of Justice (Press Release)19:45 10-Oct-24

FDA Warns Doctor Over Stem Cell Company Medpage Today19:00 10-Oct-24

Throw out these recalled vegetables immediately: FDA identifies 7 risky products Staten Island Advance, New York18:47 10-Oct-24

FDA's Promised Guidance on Pulse Oximeters Unlikely to End Decades of Racial Bias Medpage Today18:19 10-Oct-24

FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with… PR Newswire (Press Release)18:01 10-Oct-24

FDA Accepts Bayer’s NDA for Elinzanetant to Treat Menopause Symptoms Drug Topics17:48 10-Oct-24

FDA Grants Breakthrough Therapy Deignation for Volixibat in Cholestatic Pruritus From Primary Biliary Cholangitis Pharmacy Times17:31 10-Oct-24

FDA clears Vy Spine’s 3D printed spinal fusion device Verdict Medical Devices17:04 10-Oct-24

What went wrong with the plan to legalise therapeutic MDMA? Leafie16:42 10-Oct-24

Knockoff weight loss drug sellers are fighting back against Eli Lilly and the FDA Quartz16:33 10-Oct-24

Kymera’s oral STAT degrader KT-621 gains IND clearance from FDA BioWorld16:28 10-Oct-24

FDA Will Now Regulate Laboratory Developed Tests JD Supra16:28 10-Oct-24

Happy Health receives FDA clearance for smart ring MobiHealthNews15:57 10-Oct-24

TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn’s … Johnson & Johnson (Press Release)15:51 10-Oct-24

FDA authorizes over-the-counter combined Covid-19 and flu test CBS News15:37 10-Oct-24

Antag Therapeutics gets FDA clearance to start clinical trials with new obesity drug Outsourcing-Pharma.com15:33 10-Oct-24

Things to do: Cornell v. Harvard football, FDA leader, mariachi music Cornell Chronicle15:18 10-Oct-24

FDA clears Vy Spine’s 3D printed LumiVy OsteoVy PEKK Lumbar IBF Voxel Matters15:08 10-Oct-24

FDA food program is in flux Chemical & Engineering News15:06 10-Oct-24

GEHC's MIM Software to Aid Radiation Therapy With Its Latest FDA Nod Zacks14:37 10-Oct-24

1 'Strong Buy' Healthcare Stock to Scoop Up After Its Latest FDA Win Barchart14:21 10-Oct-24

As GLP-1 supply issues resolve, FDA clarifies policies American Pharmacists Association14:19 10-Oct-24

FDA Recalls Eggs Linked to Salmonella Outbreak Prevention.com14:15 10-Oct-24

InspireMD Gains FDA Premarket Approval for CGuard Prime Carotid Stent Zacks14:06 10-Oct-24

Kymera's IND Application for STAT6 Degrader Gets FDA Clearance Zacks14:06 10-Oct-24

AEYE Health's Portable Autonomous AI Screening Solution for Diabetic Retinopathy to Be… PR Newswire (Press Release)14:02 10-Oct-24

Volixibat Granted Breakthrough Therapy Designation for Cholestatic Pruritus in Primary Biliary… Business Wire (Press Release)13:37 10-Oct-24

EXAS Gains FDA Nod for Cologuard Plus, Progresses With CRC Screening Zacks13:35 10-Oct-24

Cytovale Completes $100 Million Series D Funding to Accelerate Commercial Expansion of its… PR Newswire (Press Release)13:31 10-Oct-24

Labcorp Expands Sexually Transmitted Infection (STI) Test Offerings with Rapid Syphilis Test PR Newswire (Press Release)13:31 10-Oct-24

Clearmind Medicine Announces IRB Approval for FDA First-In-Human Clinical Trial of CMND-100 at Second Clinical Site GlobeNewswire (Press Release)13:16 10-Oct-24

Achieve Life Sciences Announces Completion of Enrollment in ORCA-OL Clinical Trial & Successful Outcome of the First… GlobeNewswire (Press Release)13:06 10-Oct-24

Movano Health Provides Update on FDA Review of EvieMED Ring PR Newswire (Press Release)13:01 10-Oct-24

Melt Pharmaceuticals Announces Dosing of Last Patient in Pivotal Phase 3 Study of Its Lead… Business Wire (Press Release)12:05 10-Oct-24

Novo Nordisk Ramps Up Lawsuits Over Fake Ozempic, as Demand Skyrockets The Fashion Law12:04 10-Oct-24

Nanoscope Announces Plans to Submit BLA for MCO-010 to Treat Retinitis Pigmentosa PR Newswire (Press Release)12:04 10-Oct-24

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12 Oct 05:56

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