FDA says Elevidys shipping can start up again for ambulatory DMD patients
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Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
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Sarepta Therapeutics gets FDA green light to resume Elevidys for DMD
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FDA Says Sarepta (SRPT) Can Treat Ambulatory Patients With Gene Therapy Elevidys
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Roche gets negative EMA Committee opinion on Elevidys CMA for 3-7 year olds with Duchenne muscular...
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Full coverage of this storyUS FDA approves new oral drug for rare genetic disorder phenylketonuria
FDA Approval Sparks Bullish Momentum In PTC Therapeutics — Here’s What Happened By Stocktwits
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FDA approves sepiapterin to treat phenylketonuria in adult, pediatric patients
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Full coverage of this storyMohit Manrao: FDA Grants Priority Review for sBLA in Resectable Early-Stage Gastric and GEJ Cancers - OncoDaily
Full coverage of this storyUS targets knockoff weight-loss drugs
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Full coverage of this storyMenopause relief drug: USFDA extends review period for Bayer Elinzanetant
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Extended Elinzanetant FDA review seen as ’a small negative’ for Bayer
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FDA Extends Review Period for Bayer’s Non-Hormonal Menopause Therapy
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Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause
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Full coverage of this storyAlembic Pharmaceuticals gains USFDA final approval for Carbamazepine Extended-Release Tablets
Full coverage of this storyFDA grants fast track designation for MAIA’s lung cancer drug
Maia Biotechnology stock soars after FDA grants Fast Track designation By Investing.com
MAIA Biotechnology Receives FDA’s Fast Track Designation for Ateganosine as a Treatment for Non-Small Cell Lung Cancer
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Full coverage of this storyDr. Reddy’s Laboratories shares fall on seven observations from USFDA
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Full coverage of this storyCelcuity's breast cancer combo hits goals, teeing up FDA filing
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This Pharma Stock Rose 200% On Monday Morning And Retail Says Valuation Could Rise To $5B: Here’s Why
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Positive VIKTORIA-1 Trial Results and Favorable Safety Profile Drive Buy Rating for Geda in Metastatic Breast Cancer
Full coverage of this storyGeorge Tidmarsh named Director of Center for Drug Evaluation and Research: USFDA
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FDA Appoints Biotech Executive as Top Drug Regulator Under RFK Jr.
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Political or professional? Makary’s overhaul of CDER, CBER may reshape leadership norms
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Revelation Biosciences, Inc. Congratulates Its Former Chairman of the Board, George Tidmarsh, on His Appointment as the Head of the FDA Center for Drug Evaluation and Research
FDA names former pharmaceutical company executive to oversee US drug program
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Full coverage of this storyGlenmark Pharma receives warning letter from USFDA for Indore facility
Full coverage of this storyZydus Lifesciences shares in focus after USFDA nod for Celecoxib capsules
Zydus Lifesciences shares gain on final USFDA approval for Celecoxib capsules
Zydus Receives USFDA Nod For Celecoxib Capsules For Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis
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Zydus Lifesciences gets USFDA nod for its painkiller Celecoxib capsules
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Zydus receives final approval from USFDA for Celecoxib Capsules
Full coverage of this storyPharmalittle: We're reading about FDA 'expert panels,' knock-off weight loss drugs, and much more
By Ed Silverman
Bayer gets USFDA nod for Finerenone for new indication in heart failure patients
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Bayer Gets FDA Nod for Label Expansion of Kerendia in Heart Failure
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U.S. FDA Approves Finerenone for New Indication in Patients with Heart Failure with Left Ventricular Ejection Fraction of ≥ 40%
Full coverage of this storyFDA Changes Import Entry Review Process for Regulated Goods, Effective August 4
Full coverage of this storyLupin receives USFDA observations for two Pithampur manufacturing units
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FDA approves avatrombopag for pediatric immune thrombocytopenia, including new sprinkle formulation
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Full coverage of this storySterotaxis' Catheter Receives FDA Clearance
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Stereotaxis' MAGiC Sweep: A Strategic Inflection Point in Robotic Electrophysiology
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Full coverage of this storyFDA Clears Zymeworks Novel Liver Cancer Drug ZW251 for Clinical Trials | ZYME Stock News
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Zymeworks’ second ADC with TOPO1 inhibitor payload to enter clinic in US
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Full coverage of this storyImperative Care secures US FDA clearance for Zoom 7X catheter alongside first patient cases
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Full coverage of this storyRadiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart
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Radiopharm Theranostics Receives FDA Investigational New Drug Clearance for RV-01 Cancer Therapy
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Full coverage of this storyScientists find two FDA-approved drugs that could reverse effects of Alzheimer's disease
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Do These Two Cancer Drugs Have What It Takes to Beat Alzheimer’s?
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Scientists Find 2 Existing Drugs Can Reverse Alzheimer's Brain Damage in Mice
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Breakthrough as two FDA-approved drugs are found to reverse Alzheimer's — including restoring memory
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Study finds a combination of cancer drugs could treat Alzheimer’s
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Full coverage of this storyFDA Cracks Down on Indian Factory That Made a Drug Linked to U.S. Deaths
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Glenmark Pharmaceuticals Faces FDA Action After Report Links Its Generic Drug to US Deaths
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USFDA pulls up Glenmark for manufacturing lapses at Pithampur plant
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Glenmark Pithampur warning letter accessed by CNBC-TV18: Details here
Full coverage of this storyFDA considers warning about antidepressants during pregnancy
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Full coverage of this storySarepta Stock Drops After Downgrade and FDA Probe. The Crisis Explained.
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Why Sarepta Therapeutics Stock Surged Nearly 48% In After-Hours Trading Today By Stocktwits
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Full coverage of this storyFDA, ASCO propose principles for proper dosing in cancer drug development
Full coverage of this storyJnJ eyes expanded USFDA approval for Caplyta for prevention of relapse in schizophrenia
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Johnson & Johnson submits sNDA to U.S FDA for CAPLYTA
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Johnson & Johnson Submits Supplemental NDA for Schizophrenia Treatment Caplyta
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Full coverage of this storyUnanimous Support Across House Energy And Commerce To Reauthorize FDA's OMUFA Program
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FDA Approves Apellis' EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older
Full coverage of this storyGSK's Blenrep: Navigating FDA Hurdles and Unmet Needs in the Fight Against Multiple Myeloma
GSK Blenrep combos approved in EU for treatment of relapsed/refractory multiple myeloma
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GSK's blood cancer drug gets EU approval
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Belantamab Mafodotin Combo Has Meaningful Benefits in R/R Multiple Myeloma
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FDA OCE issues RFA for cooperative agreements for evaluation of cardiotoxicity
Full coverage of this storyA need for speed: FDA piloting voucher program to expedite drug review
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FDA opens national priority fast track, offering 2-month reviews to onshoring and affordability projects
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Full coverage of this storyIs Deodorant Safe? FDA Recalls Thousands of Power Stick Units
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Hot Weather And A Deodorant Recall, What’s Going On In Texas This Summer
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Stay Cool This Summer in Lubbock, But Check Your Power Stick Deodorants First!
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FDA recalls 67,000 cases of dangerous underarm deodorant
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Full coverage of this storyLonapegsomatropin-Tcgd Receives FDA Approval for Growth Hormone Deficiency
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Ascendis Pharma stock jumps after FDA approves SKYTROFA for adult GHD
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FDA Accepts BLA, Grants Priority Review to Tab-Cel in EBV-Positive PTLD
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Atara gets FDA priority review for Tabelecleucel application
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Full coverage of this storyThe FDA Plans to Reevaluate Fluoride Supplements
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FDA to review prescription fluoride supplements for kids at risk for tooth decay
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Health risks of removing fluoride from drinking water
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The FDA Might Ban Fluoride Supplements. Dentists Are Upset
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Fluoride in water: Doctor explains risks, benefits
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Full coverage of this storyFDA approves injectable HIV medication
Lenacapavir: After FDA approval, HIV pre-exposure prophylaxis injectable moving closer to EU approval
By R. Prasad
EU regulator backs Gilead's twice-yearly injection for HIV prevention
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The first 100% effective HIV prevention drug is approved and going global
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Does six-monthly PrEP have a future following the collapse of global HIV funding?
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Full coverage of this storyDemocrats Slap Trump’s ‘Sledgehammer’ On FDA
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Unanimous Support Across House Energy And Commerce To Reauthorize FDA’s OMUFA Program
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New Bill: Representative Robert E. Latta introduces H.R. 4273: Over-the-Counter Monograph Drug User Fee Amendments
Latta bill to improve access to over-the-counter medicines advances
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Full coverage of this storyA Record Year For US FDA Approvals? Commissioner Says It’s Possible
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The FDA is coming for your Doritos, Oreos, and other favorite snacks
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HHS, FDA and USDA Address the Health Risks of Ultra-Processed Foods
Ultra-processed food leads to obesity: The science explained
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Ultra-processed foods trigger addictive behaviors meeting clinical criteria, researchers say
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Experts dissect ‘ultra-processed foods’
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Full coverage of this storyAlembic Pharma bags USFDA nod for cancer injection Doxorubicin Hydrochloride Liposome
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RFK Jr. and other Trump officials embrace psychedelics after FDA setback
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Trump's VA Secretary Wants To 'See People Healed' With Psychedelics, But They're 'Tied Up With Regulation'
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RFK Jr. floats greenlighting psychedelic therapy. What does this mean for Oregon's psilocybin industry?
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LI drug treatment experts, veterans advocates divided over psychedelic treatment
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Psychedelic medicine has bipartisan support
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Full coverage of this story'COA-72 not approved by FDA for HIV clinical trials' – Manufacturer corrects misleading reports
AUDIO: What COA said about the application in 2019 to FDA for clinical trials of COA 72 as an anti-HIV drug
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Full coverage of this storyFDA Announces Immediate Recall of Popular Sandwiches
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Top F.D.A. Official Overrode Scientists on Covid Shots
By Christina Jewett
FDA issues alert in the United States over contamination of one of the world's most popular desserts
Popular ice cream brands recalled across US after labeling error
Consumer’s allergic reaction leads to recall of Helados Mexico and La Michoacana products
Popular Sweet Treat Recalled Across California Poses Deadly Health Risk
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Certain paletas sold at H-E-B have been recalled nationwide. Here's why.
By Polly Anna Rocha
Full coverage of this storyUS FDA approves Regeneron's blood cancer therapy
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