F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs
By Rebecca Robbins & Christina Jewett
Opinion | When accepting or rejecting new drugs, the FDA will be transparent
Opinion
By Marty Makary
FDA Rejections: We Read 200 CRLs So You Don’t Have To
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FDA to Share Rejection Letters Drugmakers Often Keep Secret
By Damian Garde & Sam Hornblower
FDA releases ‘initial batch’ of more than 200 drug rejection letters
By Gabrielle Masson
Full Coverage of this storyFDA approves 12-month flea treatment for dogs, marking veterinary breakthrough
By Docquan Louallen
FDA approves shot that protects dogs from fleas and ticks for 8-12 months
By Anthony Robledo
Blockbuster long acting flea and tick treatment for dogs coming after FDA approval
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Bravecto Quantum: A Paradigm Shift in Pet Care and Merck's Path to Dominance
QUANTUM (Fluralaner for Extended-Release Injectable Suspension) from Merck Animal Health
Full Coverage of this storyModerna gets full US approval for COVID shot in at-risk children 6 months and older
By Sriparna Roy & Bhanvi Satija
Moderna COVID shot for kids cleared in face of RFK Jr. criticism
FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
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Moderna gets full FDA approval for kids COVID-19 vaccine
By Meg Hilling
MRNA Stock Up on Full FDA Nod for COVID-19 Jab in Pediatric Patients
Full Coverage of this storyFDA Offers to Trade Faster Drug Reviews for Lower US Prices
By Rachel Cohrs & Sam Hornblower
FDA's Makary calls for tying fast-review vouchers to lower US prices, without specifics
By Andrew Dunn
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
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Understanding The Commissioner's National Priority Voucher
FDA Voucher Reforms: A Golden Opportunity in Biotech Valuations
Full Coverage of this storyCapricor Plunges on FDA Rejection of DMD Cell Therapy
By Tristan Cesar Manalac
Full Coverage of this storyUS FDA approves gradual dosing for Lilly Alzheimer's drug
By Deena Beasley
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease | Eli Lilly and Company
FDA Approves Updated Donanemab Labeling, BLA Accepted for Tividenofusp Alfa, Nipocalimab Outperforms FcRn Blockers
FDA Approves Modified Titration Dosing for Donanemab-azbt to Reduce ARIA-E Incidence in Early AD
What a New Dosing Plan Could Mean for People on Alzheimer’s Drug Kisunla
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Full Coverage of this storyImmunityBio: High Stakes On ANKTIVA's Growth Amidst FDA Friction And Financial Pressures
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Full Coverage of this storyInside the Collapse of the F.D.A.
By Jeneen Interlandi
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
By Debbie Cenziper, Katherine Dailey & Megan Rose
Inside the staff exodus and tanking morale that threaten Makary’s FDA
By Lizzy Lawrence
FDA Faces Wave of Resignations Amid Staff Dissatisfaction and Workplace Challenges
US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says
By Derrick Gingery
Full Coverage of this storyUS FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder
Ultragenyx gets Complete Response Letter for Sanfilippo syndrome gene therapy
By Jonathan Block, MPH
Ultragenyx's Gene Therapy Delay: A Speed Bump on the Road to Lifesaving Innovation?
Ultragenyx gets FDA complete response letter for Sanfilippo gene therapy
By Anna Bratulic
Ultragenyx Receives FDA Response on UX111 Application
Full Coverage of this storyDaily CBD Use at Consumer-Level Doses May Elevate Liver Enzymes, FDA-Led Trial Shows
Full Coverage of this storyE-cig businesses sue Wisconsin Department of Revenue over FDA authorization law
By Noah Cornelius
Wisconsin law cracking down on e-cigarettes just took effect. Now, distributors are suing.
By Madeline Heim
L:awsuit Challenges Wisconsin's PMTA Registry Law
By Jim Mcdonald
Vaping retailers mount challenge to 2023 Wisconsin law they say would end their business
By Chris Rickert
Wisconsin’s ban on many popular vapes met with pushback
By Sophia Lauber
Full Coverage of this storyFDA Grants Orphan Drug Designation to Quemliclustat in Pancreatic Cancer
By Tim Cortese
Arcus wins FDA orphan status for cancer drug (RCUS:NYSE)
By Nilanjana Basu
Arcus Biosciences' Investigational Pancreatic Cancer Treatment Gets US FDA Orphan Drug Status
Arcus Biosciences' Quemliclustat Gets Orphan Drug Status For Pancreatic Cancer
Arcus' Pancreatic Cancer Drug Gets FDA Orphan Status as Phase 3 Trial Nears Full Enrollment
Full Coverage of this storyFDA Clears AI-Based Visualization Software for Surgical Breast Cancer Care
By Russ Conroy
AI startup SimBioSys gets OK for breast cancer surgery platform
By Jon Asplund
SimBioSys Secures Third FDA Clearance for TumorSight™ Viz, Advancing AI-Powered Precision Surgery in Breast Cancer Care
U.S. FDA clears latest version of SimBioSys’s breast cancer platform
SimBioSys Earns 3rd FDA OK for TumorSight Viz AI Breast Cancer Tool
By Sam Brusco
Full Coverage of this storyThis Week at FDA: Makary celebrates first 100 days, Senate committee passes FDA budget bill, and more
By Ferdous Al-Faruque
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
Opinion
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FDA Commissioner: ‘We want to focus on food’
By Diana Falzone
FDA leader touts achievements of first 100 days; NIH will cap publishing fees while disseminating research results
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Hour 2 - Curing the Culture with MAHA | iHeartRadio | The Clay Travis and Buck Sexton Show
Full Coverage of this storyInfant breathing system could cause serious injury or death, FDA recall warns
By Alexia Partouche
Full Coverage of this storyFDA announces investigations into Salmonella, E. coli and Hepatitis A Outbreaks with no sources
By William Marler
Michelle Pfeiffer Torches Bill Gates Over ‘Concerning’ FDA Approval
By Kenneal Patterson
Michelle Pfeiffer slams ‘very concerning’ FDA-approved food technology once backed by Bill Gates
By Connor Surmonte
Michelle Pfeiffer slams Bill Gates
Michelle Pfeiffer blasts ‘very concerning’ FDA-approved food technology once backed by Bill Gates
By Breanna Bell
Does Bill Gates have any connection with Apeel Sciences? Michelle Pfeiffer critiques the food tech brand as it receives FDA approval
Full Coverage of this storyFDA: Boar's Head Deli Brand Has Initiated Another Grocery Recall, This Time Affecting One State
By Kristine Gasbarre
Flu Vaccine Shots Will Be Available This Fall Afterall
By Carol Ann Rinzler
Full Coverage of this storyLawmakers advance $27B funding bill tackling FDA funding, hemp, farm loans
By Therese Boudreaux
FDA May Fast Track Drug Reviews for Lower US Prices
NANOBIOTIX Announces Regulatory Harmonization and New Composition of Matter Patent Filed for JNJ-1900 (NBTXR3)
Nanobiotix Advances JNJ-1900 with Regulatory and Patent Milestones
Nanobiotix’ NBTXR3 secures reclassification in Europe
Nanobiotix Cancer Drug JNJ-1900 Gains EU Regulatory Alignment, Files New Patent | NBTX Stock News
Full Coverage of this storyTop F.D.A. Official Overrode Scientists on Covid Shots
By Christina Jewett
FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff
By Matthew Perrone
Trump-Kennedy attacks on vaccines and public health will kill millions globally
By Evan Blake
RFK Jr.'s FDA officials overrode career staff to limit COVID shots
By Alexander Tin
RAW: FILE: FDA OFFICIAL OVERRODE SCIENTISTS ON COVID VAX USE
Full Coverage of this storyFDA Issues Dire Warning For Two Recalled Chocolate Products
By Mike Moraitis
FDA Issues Highest Risk Warning for Nationwide Chocolate Recall
By Matthew Robinson
Weaver Nut Company Recalls Chocolate Nonpareils Due to Undeclared Milk Allergen
By Alexandria Portee
Weaver Nut Company chocolate recall under FDA's highest risk level
By Anthony Robledo
Popular chocolate treat recalled due to ‘presence of allergen’
By Amber Raiken
Full Coverage of this storyHIV prevention drug hailed as a 'breakthrough' gets FDA approval
By Jonathan Lambert
The Drug That Could Revolutionize the Fight Against H.I.V.
By Jon Cohen
FDA approves powerful HIV prevention drug: What to know about Yeztugo
By Benjamin Ryan
'Miracle' HIV drug lenacapavir approved amid US budget cuts
Uptake of Gilead's Yeztugo will be swift, analyst says after discussion with HIV doc
By Kevin Dunleavy
Full Coverage of this storyFDA halts new clinical trials that export Americans' cells to foreign labs in hostile countries for genetic engineering
FDA blocks new clinical trials that ship cells from US to China
By Paul Taylor
Politics Over Patients? FDA’s Ban on Overseas Sample Processing Undermines U.S. Biomedicine
FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”
Fierce Pharma Asia—AZ-CSPC deal; FDA's American cell shipping ban; China's trial review acceleration plan
By Angus Liu
Full Coverage of this storyNew FDA priority review drug program comes with risks, questions
By Matthew Herper
Massive Egg Recall Update: One Dead, 134 Infected
By Olivia Bria
Full Coverage of this storyFDA removes barrier to CAR-T therapies access
By Angus Liu
Full Coverage of this storyBoston Scientific’s (BSX) FARAPULSE Approved by FDA for Expanded Labeling
Full Coverage of this storyThe Secret Gamble at the FDA That Exposed Americans to Risky Drugs
By Debbie Cenziper, Irena Fischer-Hwang & Brandon Roberts
Pune’s Iconic Cafe Goodluck Faces FDA Action After Glass Shards Found In Bun Maska, License Suspended
"Thought It Was Ice": Man Finds Glass In Bun Maska At Pune's Goodluck Cafe
'At first, I thought it was ice': Customer claims glass shard found in bun maska at iconic cafe in Pune;
By Anjali Jhangiani
VIDEO: Glass Shard Found In Bun Maska At Pune’s Iconic Goodluck Cafe
Glass Found in Bun Maska at Pune’s Cafe Goodluck, Video Goes Viral
By Chaitraly Deshmukh
Full Coverage of this storyCancer Gene Therapy Market Booming as FDA Approvals and Trials
Gene Therapy Market to Hit US$36.55 Billion by 2032 with 19.4% CAGR | MarketsandMarkets™
CTO East Coast 2025: Global oncology cell therapy market to hit $25bn by 2031
By Ross Law
Cell and Gene Therapy CDMO Market Booms with 27.94% CAGR; Oncology and Preclinical Segments Dominate in 2025
Cell and Gene Therapy Market Attracts Biotech Giants, Growing
Full Coverage of this story