60 stories tagged with #fda, in publish-time order across the WeSearch catalog. Tag pages update as new stories ingest.
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Inside the Trump admin's push to integrate AI into the healthcare system, including an FDA regulatory fast track for digital health tech like AI chatbots (Elizabeth Dwoskin/Washington Post)
Elizabeth Dwoskin / Washington Post : Inside the Trump admin's push to integrate AI into the healthcare system, including an FDA regulatory fast track for digital health tech like …
STAT+: Will Makary’s FDA voucher program survive?
RevMed's cancer drug feels out of reach for some, SCOTUS preserves key generic drug pathway, and more biotech news…
Replimune: Modeling The Coin Flip Of FDA Approval
Replimune (REPL) faces a binary FDA decision on RP1 in advanced melanoma. RP1 approval could push REPL to $14.99/share. See more here.…
What America Needs From a New FDA Commissioner
Dear Readers,…
STAT+: Drug companies, patient groups urge FDA to pause commissioner’s voucher program
The White House has used the program to reward companies that help its political goals.…
U.S. FDA issues VAI classification to Granules arm Virginia facility
U.S. FDA classifies Granules Pharmaceuticals' Virginia facility with VAI status, indicating found issues but no immediate regulatory action.…
U.S. FDA issues warning letter to Zydus Lifesciences’ Baddi formulation unit
The U.S. Food and Drug Administration (U.S. FDA) has issued a warning letter to Zydus Lifesciences relating to the company’s formulation manufacturing facility in Baddi, Himachal P…
The FDA is moving faster on psychedelics — now Washington must do more
In response to Trump's recent executive order, the FDA announced plans to expedite the review of certain psychedelic medicines for mental health conditions.…
Palvella completes pre-NDA meeting with FDA for rapamycin gel
MannKind At An Inflection Point: Pediatric Expansion Drives The Story
MannKind’s Afrezza wins FDA approval for pediatric use—unlocking growth and a $300–500M opportunity. Read here for more on MNKD stock.…
Treatment for millions of Americans at stake in ‘skinny label’ Supreme Court case
The Supreme Court will soon decide a case that could upend the balance built into a bipartisan law that has accelerated the launch of generic drugs and saved American patients, emp…
As FDA misses deadline on electric shock ban, disability advocates speak out
The FDA has missed a self-imposed deadline to ban the use of electrical shock devices in people with intellectual disabilities.…
Inaction has consequences: Mail-order mifepristone is midterm game-changer
Inaction on the abortion drug crisis will not come without consequences for this year’s midterm elections. As post-Dobbs v. Jackson Women’s Health Organization retaliation dressed …
‘Sexual Chocolate’ Faces Recalls After FDA Tests Reveal Undisclosed Viagra
Sellers of products with names like Boner Bears and DTF have voluntarily recalled their products after testing positive for the active ingredients in Viagra and Cialis.…
STAT+: BioNTech and Pfizer tout bispecifics data, and Pazdur sees silver lining at FDA
ASCO, Day 2: promising news around lung cancer, new immunotherapies, and bold words from Rick Pazdur.…
STAT+: China competition, ‘destruction’ at FDA gives agency chance to restructure, Rick Pazdur says
Rick Pazdur on the FDA: “We've had a lot of destruction here, and it doesn't mean that we have to just go back and say, well, let's rebuild it as it was."…
FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
A Drama-Free FDA Is a Win for the White House
Trump’s FDA Course Correction Is a Win for Consumers
In the span of a week, the administration has taken two important steps in the right direction. First, the Food and Drug Administration moved forward on flavored vaping products fo…
MannKind Corporation (MNKD) Discusses FDA Approval of Afrezza for Pediatric Diabetes Patients Ages 6 and Older Transcript
MannKind Corporation (MNKD) Discusses FDA Approval of Afrezza for Pediatric Diabetes Patients Ages 6 and Older May 29, 2026 4:30 PM EDTCompany...…
‘Holy grail’ sleep apnea pill can cut episodes by more than 50%
It could prove to be a saving grace for the roughly 80 million Americans who suffer from sleep apnea.…
Guselkumab Adds PsA Structural Damage Inhibition to Label
Guselkumab is the only IL-23 inhibitor that has been proven to help stop further structural damage in patients with active psoriatic arthritis.…
US FDA approves MannKind’s inhaled insulin for children
SurGenTec Secures FDA Clearance for ION-C™ - Now Navigation Compatible - Morningstar
Comprehensive up-to-date news coverage, aggregated from sources all over the world by Google News.…
The FDA’s problem isn’t personnel — it’s enforcement
The sensationalist speculation about Makary’s departure from the FDA deflects from the agency’s deep-rooted administrative failures.…
FDA Advisors Favor XFG Strain for Next COVID Vaccine
Experts skipped the cicada variant BA.3.2 and last year’s LP.8.1 vaccine strain and recommended monovalent XFG option.…
Replimune is resubmitting its twice-rejected melanoma drug after FDA leadership exodus
Replimune to resubmit twice-rejected drug for approval after FDA shakeup
Replimune was among the drugmakers that had criticized the FDA for what they called inconsistent guidance around trials and approvals.…
Tempus stock rises after FDA approval for tumor-only test
Tempus AI receives FDA approval for tumor-only genomic test
Replimune stock surges 40% on FDA approval path agreement
FDA approves expanded Tremfya label for joint damage inhibition
Durvalumab Plus BCG Earns FDA Nod for Bladder Cancer
The combination therapy is approved for BCG-naive patients with high-risk non-muscle-invasive disease.…
FDA panel recommends updating covid shots to target XFG strain
XFG, nicknamed “stratus,” carries mutations that could help it partially dodge Covid antibodies.…
FDA Recalls Boner Bears ‘Sex Chocolate’ Over Undeclared ‘Viagra’ Ingredient
Fast Acting Max Strength…
'A landmark moment for the field': FDA approves first-ever gene therapy for inherited deafness
FDA Breakthrough Device Designation Marks Major Milestone for Gene Solutions' SPOT-MAS 10 Multi-Cancer Screening Test - Morningstar
Comprehensive up-to-date news coverage, aggregated from sources all over the world by Google News.…
AbbVie receives FDA approval for BPDCN blood cancer treatment
Compass Pathways: A Trip Worth Taking Before The FDA Verdict
Natera: A Growing Biotech, After Recent FDA Approval And Q1 Revenue Results
Natera (NTRA) stock outlook: Buy rating reaffirmed on FDA approval, 38% Q1 revenue growth and FY26 guidance raise.…
FDA grants orphan drug exclusivity for Precigen’s PAPZIMEOS
FDA accepts Nuvalent’s neladalkib application with priority review
FDA extends review period for AstraZeneca’s camizestrant breast cancer application
Alabama warns healthcare providers against use of non-FDA-approved peptides
FDA advisers to weigh updated COVID vaccine targeting XFG subvariant
Tom Cotton warns FDA about cybersecurity threat from Chinese-made medical devices
Sen. Tom Cotton sent a letter to the acting FDA commissioner requesting tougher cybersecurity restrictions on Chinese-made medical devices.…
FDA panel to weigh Covid vaccine update targeting XFG variant
US FDA advisers to weigh updating 2026-27 COVID vaccines for XFG variant
Focus: Big Tobacco comes out on top after US FDA shake-up - Reuters
Comprehensive up-to-date news coverage, aggregated from sources all over the world by Google News.…
Outlook Therapeutics stock surges after winning FDA appeal
Cingulate stock reaffirmed at Buy by H.C. Wainwright ahead of FDA decision
Datroway receives US FDA approval for first-line triple-negative breast cancer
The FDA opened a gaping loophole for flavored vapes
Weight-Loss Pill Approval Highlights Important Role of PCPs
FDA approval of Eli Lilly’s weight-loss pill on April 1 shows the fast-changing landscape for weight loss, obesity medications.…
STAT+: How Kyle Diamantas defied expectations as he rose to lead the FDA
WASHINGTON — People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top…
Poolbeg Pharma receives FDA feedback on cancer therapy POLB 001
FDA Approves Bulevirtide for Hepatitis Delta Virus
Bulevirtide (Hepcludex; Gilead Sciences, Inc.) is the first FDA-approved treatment for chronic hepatitis delta virus infection.…
Raaw Energy issues recall on dozens of products over listeria fears
A popular raw dog food brand is expanding a recall of dozens of products over fears they may be contaminated with Listeria monocytogenes.…
FDA Staff Blindsided by E-Cigarettes & Nicotine Policy
The Associated Press has learned that officials at the Food and Drug Administration were blindsided by a recent policy change allowing more electronic cigarettes and nicotine pouch…
Dr. Deborah Birx says "there's a deep bench" to CDC, FDA to respond to Ebola
Dr. Deborah Birx, who helped coordinate the international response to the 2014 Ebola outbreak, told "Face the Nation with Margaret Brennan" that "there's a deep bench" at the CDC, …