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FDA

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FDA

FDA approves Injectafer for iron deficiency in heart failure adult patients Pharmaceutical Technology09:27Injectafer Health

FDA grants first HF indication for IV iron to ferric carboxymaltose TCTMD14:19Injectafer Health

US FDA approves Pfizer's RSV vaccine Reuters18:00Pfizer Vaccine Respiratory Syncytial Virus Pfizer

Pfizer’s RSV vaccine approved by FDA for older adults PMLiVE07:52Pfizer Vaccine Respiratory Syncytial Virus Pfizer

FDA greenlights imports of China cancer drug with up to 90% cure rate Mail Online12:30Cancer Pharma Business (US)

FDA will allow import of chemo Drug from China amid dire shortage Kaiser Health News08:21Cancer Pharma Business (US)

FDA: Nix off-brand weight-loss drugs The Columbian, Washington09:22Semaglutide Pharma

FDA warns about safety of 'off-brand' versions of Ozempic, Wegovy ABC7 / KABC-TV13:59Semaglutide Pharma

Medicare Still Won’t Pay for Alzheimer’s Drugs without Confirmatory Data PharmTech.com15:41Alzheimer's Medicare Pharma

Medicare to provide limited coverage of new Alzheimer's drugs upon FDA approval UPI11:58Alzheimer's Medicare Pharma

GSK receives FDA file acceptance for Jemperli plus chemotherapy for treating endometrial cancer Pharmafile06:41Jemperli GSK Pharma

GSK's cancer drug Jemperli gets file acceptance from US FDA Reuters03:06Jemperli GSK Pharma

FDA approval boosts Elon Musk-owned Neuralink's valuation to $5 billion NewsBytes10:25Neuralink Elon Musk Pharma

Elon Musk's Neuralink brain implant approved for human trials in the US — Is it safe? Inverse14:23Neuralink Elon Musk Pharma

People are confusing 'poppers' for energy shots — and dying, FDA warns New York Post16:16Energy/Utilities Pharma

The FDA says people are confusing poppers with energy shots, and dying. Experts want proof CBC.ca04:47Energy/Utilities Pharma

FDA finalizes arsenic limits in apple juice WCPO TV, Ohio15:07Apple juice Arsenic Ohio

FDA caps inorganic arsenic in apple juice at 10 ppb – 10 years after proposing the limit FoodNavigator.com (USA)10:29Apple juice Arsenic Ohio

Tristel shares rise as FDA approves ultrasound disinfectant Proactive Investors (UK)08:23Tristel Alternative Investment Market Business (US)

Tristel shares soar amid US FDA approval for ultrasound disinfectant London South East05:26Tristel Alternative Investment Market Business (US)

Latest News

In the last hour

Why Mounjaro Works So Well for Weight Loss TIME12:32

FDA greenlights imports of China cancer drug with up to 90% cure rate Mail Online12:30

In the last 2 hours

Why Bausch Health Companies Stock Is Tanking Today The Motley Fool12:02

FDA Grants Priority Review to Dostarlimab Plus Chemo for dMMR/MSI-H Endometrial Cancer OncLive11:48

FDA Clears Prostate Cancer Treatment Lynparza Drug Topics11:31

In the last 4 hours

FDA: Don't use off-brand versions of Ozempic, Wegovy FOX13 Seattle11:14

Blindness biotech Alkeus Pharmaceuticals raises $150M to push Stargardt disease candidate toward FDA ENDPOINTS11:09

Bausch Health Shares Drop After Norwich Sues FDA for Final OK for Rival Drug MarketWatch11:06

FDA Approves New Indication for Letermovir for Prevention of Cytomegalovirus in Adult Kidney Transplant Recipients Pharmacy Times10:47

FDA to allow temporary overseas production to shore up supplies of chemo drug FiercePharma10:46

US FDA staff flag no new safety issues for Sanofi-AstraZeneca's preventive RSV therapy Reuters10:37

Just In Time For Pride, the FDA Is Fear-Mongering About Poppers Motherboard10:21

Reps. Eshoo, Barragán Urge Medicare Administrator for Greater Clarity on Alzheimer’s Treatment Coverage Congresswoman Anna Eshoo (Press Release)10:12

Harmony Biosciences Announces Positive Phase 2 Signal Detection Study Evaluating Pitolisant For Excessive Daytime… BioSpace10:09

Brand Institute Partners with Lexicon Pharmaceuticals on the Brand Name Development for… PR Newswire (Press Release)10:07

FDA Announces Additional Steps to Modernize Clinical Trials U.S. Food and Drug Administration (Press Release)10:06

FDA rebuffs demand to release list of U.S. pork importers Focus Taiwan10:06

TScan Therapeutics Shares Rise 17% After FDA Clears IND for Cancer Treatment MarketWatch10:05

CTP Announces Regulatory Science Forum Tobacco Reporter Magazine10:04

FDA Removes Expert with Ties to Eisai, Biogen from Leqembi Adcomm BioSpace09:59

STAT Plus: More than 200 FDA staffers have retired in less than a year STAT09:42

STAT Plus: Pharmalittle: Merck sues U.S. to halt Medicare drug-price negotiation; FDA oncology… STAT09:32

The anti-vaxxer threat keeps spreading Salon.com09:28

In the last 6 hours

FDA approves INJECTAFER for iron deficiency in heart failure adult patients Pharmaceutical Technology09:27

FDA: Nix off-brand weight-loss drugs The Columbian, Washington09:22

Skineez' Newly Announced T.E.D. HOSE, the Only FDA Cleared Hydrating Anti-Embolism Stockings… PR Newswire (Press Release)08:48

Masimo wins FDA approval for Radius VSM monitor Verdict Medical Devices08:24

FDA Will Allow Import Of Chemo Drug From China Amid Dire Shortage Kaiser Health News08:21

AVATAR MEDICAL Receives FDA Clearance For its Virtual Reality Surgical Planning Solution Business Wire (Press Release)08:04

TScan Therapeutics Announces FDA Clearance of Investigational New Drug Application for TSC-200-A0201 Targeting HPV16 to … BioSpace07:36

California man faces 21 years for trying to smuggle in frozen, roasted eels East Bay Times07:27

In the last 8 hours

Merck Gets FDA Expanded OK for Prevymis in Kidney Transplant Patients >MRK MarketWatch07:21

Teleflex Announces the Arrow® EZ-IO® Needle Is Now FDA Cleared For Use in an MRI EnvironmentFirst and Only IO Needle… BioSpace07:16

Candesant Biomedical Announces $35M in Series B Financing to Advance Commercialization of… PR Newswire (Press Release)07:03

Vyluma Announces FDA Acceptance of New Drug Application for NVK002, Its Novel Investigational Treatment for Pediatric… GlobeNewswire (Press Release)07:02

ANeuroTech receives FDA approval for Phase IIIb MDD drug trial Clinical Trials Arena06:53

U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of… Business Wire (Press Release)06:53

Artelon, Inc.'s FlexBand®, FlexPatch®, and FlexBand Plus® earn FDA Clearance for Ligament Reinforcement BioSpace06:45

GSK receives FDA file acceptance for Jemperli plus chemotherapy for treating endometrial cancer Pharmafile06:41

Teleflex Announces the Arrow® EZ-IO® Needle Is Now FDA Cleared For Use in an MRI Environment GlobeNewswire (Press Release)06:31

Masimo secures FDA 510(k) clearance for Radius VSM vital signs monitor NS Medical Devices06:17

BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review NurOwn®… PR Newswire (Press Release)06:05

Earlier today

Sparrow receives FDA approval for smartphone stethoscope Verdict Medical Devices04:51

US FDA accepts GSK's licence application for cancer treatment Jemperli London South East03:41

Alkeus raises funds to launch Stargardt disease therapy gildeuretinol Pharmaceutical Technology03:30

Biosyngen's Cell Therapy BRG01 Granted Orphan Drug Designation by the U.S. FDA for Treatment of Nasopharyngeal Cancer AsiaOne03:07

FDA Allows Chemo Imports from China; TB Patient Jailed; 'Forever Chemicals' Lawsuit Medpage Today03:06

GSK's cancer drug Jemperli gets file acceptance from US FDA Reuters03:06

DeepX Diagnostics Inc.'s DermoSight Receives FDA Clearance for Teledermatology Screening of Suspect Skin Cancer Lesions BioSpace03:01

US FDA accepts GSK supplemental application for Jemperli cancer drug ShareCast02:28

GSK receives US FDA file acceptance for Jemperli (dostarlimab) plus chemotherapy for the treatment of dMMR/MSI-H… GlaxoSmithKline (Press Release)02:17

GSK Gets FDA File Acceptance For Jemperli Endometrial Cancer Treatment MarketWatch02:16

Yesterday

FDA Cracking Down on Unapproved HCT/Ps with Fourth Untitled Letter of 2023 JD Supra18:36 5-Jun-23

Pomona man faces 21 years for trying to smuggle in frozen, roasted eels San Gabriel Valley Tribune, California18:12 5-Jun-23

FDA Warns Against Skin Condition Molluscum Products NewsMax17:33 5-Jun-23

FDA Head Says Drug Shortages ‘Out of Our Control’ Pain News Network17:23 5-Jun-23

STAT Plus: FDA removes neurologist with financial ties to Eisai and Biogen from Alzheimer’s… STAT17:05 5-Jun-23

FDA Warns Against Using Bogus Treatments for Molluscum HealthDay16:34 5-Jun-23

U.S. allows chemotherapy drug imports from overseas manufacturers USA Today16:34 5-Jun-23

People are confusing 'poppers' for energy shots — and dying, FDA warns New York Post16:16 5-Jun-23

Musk says Neuralink will bring 'close symbiosis' with artificial intelligence Washington Examiner16:16 5-Jun-23

Medicare Still Won’t Pay for Alzheimer’s Drugs without Confirmatory Data PharmTech.com15:41 5-Jun-23

BioBlast w/e 2 Jun 23 Lexology15:28 5-Jun-23

Unpacking FDA’s Very Low Nicotine Plan Convenience Store Decisions15:23 5-Jun-23

EMA Seeks Clarification Regarding Electronic Nicotine Products Convenience Store Decisions15:23 5-Jun-23

Canadian biotech narrows trial population to lift solid tumor drug out of FDA hold FierceBiotech15:17 5-Jun-23

FDA to import versions of common cancer drug cisplatin to alleviate shortage ENDPOINTS15:10 5-Jun-23

After selling Rubraca, Clovis Oncology unveils rejection for potential label expansion of PARP inhibitor ENDPOINTS15:00 5-Jun-23

Health Care Week in Review: Congress Raises Debt Ceiling, CMS Issues Final Rule JD Supra14:52 5-Jun-23

Timber Pharmaceuticals Soars as FDA Removes Hurdle TipRanks14:26 5-Jun-23

To ease cancer drug shortage, FDA will allow imports from China NBC News14:23 5-Jun-23

Elon Musk's Neuralink Brain Implant Approved for Human Trials in the US — Is It Safe? Inverse14:23 5-Jun-23

STAT Plus: FDA oncology head wants advisory panels to keep voting on new drugs STAT14:21 5-Jun-23

FDA Grants First HF Indication for IV Iron to Ferric Carboxymaltose TCTMD14:19 5-Jun-23

Galera Presents Additional Chronic Kidney Disease Data from ROMAN Trial at 2023 ASCO Annual Meeting GlobeNewswire (Press Release)14:17 5-Jun-23

SPONSORED: Tiny valves making a big difference for emphysema patients 6 ABC / WPVI-TV14:15 5-Jun-23

FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials JD Supra14:11 5-Jun-23

FDA Launches Food Safety Equivalence Webpage Food Safety Magazine13:34 5-Jun-23

Food Wholesaler Pleads Guilty to Smuggling Tainted Chinese Eel U.S. Department of Justice (Press Release)12:42 5-Jun-23

FDA collects another 6,000 complaints—including 40 deaths—linked to Philips’ CPAP recall FierceBiotech12:14 5-Jun-23

Paid Eisai consultant Dave Weisman backs out of temporary adcomm role for Leqembi ENDPOINTS12:08 5-Jun-23

Virtual Incision Announces De Novo Request for Robotic Assisted Surgical System Under FDA Review Robotics 24/712:07 5-Jun-23

FDA Revokes Authorization of J&J’s Covid Vaccine as Demand Wanes BNN Bloomberg11:34 5-Jun-23

EMA Seeks Clarification From FDA Regarding Electronic Nicotine Products Convenience Store Decisions11:29 5-Jun-23

US FDA delays decision on SpringWorks Therapeutics' tumor treatment Reuters11:11 5-Jun-23

FDA lifts clinical hold on Foghorn’s study for blood and bone marrow cancer treatment ENDPOINTS10:57 5-Jun-23

FDA Approves First Intravenous Iron Replacement Therapy for Adults With Heart Failure, Iron Deficiency Pharmacy Times10:54 5-Jun-23

Rabies vaccine gets phase 3 trial approval Labiotech10:47 5-Jun-23

Ready for Guidance #263? New antibiotics regs kick in this week DairyReporter.com10:42 5-Jun-23

India's Intas gets more bad news from FDA with import alert FiercePharma10:41 5-Jun-23

GE HealthCare launches new technology that cuts MRI heart scans by up to 83% Verdict Medical Devices10:41 5-Jun-23

Foghorn Soars after FDA Lifts Hold on Phase 1 Study of Lead Candidate TipRanks10:32 5-Jun-23

FDA approval boosts Elon Musk-owned Neuralink's valuation to $5 billion NewsBytes10:25 5-Jun-23

FDA rejects Clovis' long shot bid for approval of Rubraca FiercePharma10:21 5-Jun-23

FDA warns against unapproved treatments for skin condition molluscum UPI10:08 5-Jun-23

Timber Pharma Shares Rise 60% After FDA Grants CARC Waiver to TMB-001 MarketWatch09:59 5-Jun-23

FDA Proposes Streamlined Medication Handouts PharmTech.com09:56 5-Jun-23

CSL Vifor Says FDA Grants Partner American Regent Approval For Injectafer To Treat Iron Deficiency RTT News09:36 5-Jun-23

T2 Biosystems Announces Submission for FDA Breakthrough Device Designation for Candida Auris Diagnostic TestCompany… BioSpace09:31 5-Jun-23

[PREMIERING, 2PM ET] FDA Makes Unexpected Ivermectin Announcement | Facts Matter The Epoch Times09:23 5-Jun-23

Foghorn finally has clear route back to clinic after FDA lifts yearlong hold on blood cancer… FierceBiotech09:21 5-Jun-23

T2 Biosystems Announces Submission for FDA Breakthrough Device Designation for Candida Auris Diagnostic Test GlobeNewswire (Press Release)09:11 5-Jun-23

INJECTAFER® Approved in the U.S. for the Treatment of Iron Deficiency in Adult Patients with… Business Wire (Press Release)09:09 5-Jun-23

Injectafer® approved in the U.S. for the treatment of iron deficiency in patients with heart… PR Newswire (Press Release)09:01 5-Jun-23

CTMC Marks One Year of Accelerating Life-Saving Cell Therapies to Patients Business Wire (Press Release)08:59 5-Jun-23

Tristel shares rise as FDA approves ultrasound disinfectant Proactive Investors (UK)08:23 5-Jun-23

Galderma Receives FDA Approval For Its Newest Hyaluronic Acid Filler, Restylane® Eyelight PR Newswire (Press Release)08:10 5-Jun-23

FDA Clears Sparrow’s Smartphone Stethoscope For Use by Medical Professionals Business Wire (Press Release)08:09 5-Jun-23

GE HealthCare Introduces Sonic DL: A Groundbreaking, FDA-Cleared AI Deep Learning Technology… Business Wire (Press Release)08:04 5-Jun-23

Masimo Announces FDA 510(k) Clearance of Radius VSM™ Business Wire (Press Release)08:02 5-Jun-23

Advanced Medical Solutions upbeat on US FDA approvals London South East07:49 5-Jun-23

Foghorn Therapeutics Shares Rally Premarket as FDA Lifts Clinical Hold >FHTX MarketWatch07:47 5-Jun-23

SpringWorks Therapeutics: FDA Extends Review of Nirogacestat >SWTX MarketWatch07:27 5-Jun-23

ANeuroTech receives IND approval from the FDA for pivotal Phase IIIB trial of adjunctive anti-depression drug, ANT-01 GlobeNewswire (Press Release)07:08 5-Jun-23

Crown Aesthetics Expands Further into the Asia Pacific Region PR Newswire (Press Release)07:06 5-Jun-23

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6 Jun 12:32

FDA News

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