FDA Unveils New Regulation Portal for Food Program
Regulation
FDA Unveils New Regulation Portal for Food Program
2024-01-29 17:52:05
by Dan McCue

WASHINGTON — The Food and Drug Administration has unveiled a new website detailing the Foods Program regulations it plans to publish through October 2024. The web portal, which will also list longer-term regulations the agency is prioritizing for publication at... Read More

FDA Issues First Approval for Large-Scale Drug Imports From Canada
Regulation
FDA Issues First Approval for Large-Scale Drug Imports From Canada
2024-01-05 20:09:49
by Dan McCue

WASHINGTON — The Food and Drug Administration on Friday authorized Florida to purchase millions of dollars' worth of medications from Canada, a move long opposed by the pharmaceutical industry. The goal of the approval is to give states access to... Read More

FDA Issues Recall Alert for Hypoallergenic Infant Formula
Health
FDA Issues Recall Alert for Hypoallergenic Infant Formula
2024-01-02 22:39:11
by Dan McCue

WASHINGTON — A popular hypoallergenic infant formula has been voluntarily recalled by its manufacturer due to possible Cronobacter sakazakii contamination. The formula, Nutramigen Hypoallergenic Infant Formula Powder, is manufactured by Reckitt/Mead Johnson Nutrition. According to an alert issued by the... Read More

FDA Approves a CRISPR-Based Medicine to Treat Sickle Cell Disease
Health Tech
FDA Approves a CRISPR-Based Medicine to Treat Sickle Cell Disease
2023-12-08 20:01:49
by Dan McCue

WASHINGTON — The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology for the treatment of sickle cell disease. The new treatment, called Casgevy, was manufactured by Vertex Pharmaceuticals, of Boston, Massachusetts, and... Read More

FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
Health
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
2023-11-28 15:54:36
by Dan McCue

WASHINGTON — The Food and Drug Administration on Tuesday approved Ogsiveo tablets for adult patients with progressing desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive, invading surrounding structures and organs,... Read More

FDA Clears First COVID-19 Home Antigen Test
In The News
FDA Clears First COVID-19 Home Antigen Test
2023-11-10 17:00:18
by Dan McCue

WASHINGTON — The Food and Drug Administration has approved the sale of the first over-the-counter antigen test for COVID-19. The product, ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home... Read More

FDA Establishes New Advisory Committee on Digital Health Technologies
Health Tech
FDA Establishes New Advisory Committee on Digital Health Technologies
2023-10-18 17:49:28
by Dan McCue

WASHINGTON — The Food and Drug Administration is creating a new Digital Health Advisory Committee to help the agency assess and deal with the complex scientific and technical issues related to the burgeoning market of new digital health technologies. These... Read More

FDA Authorizes Updated Novavax COVID-19 Vaccine 
Health
FDA Authorizes Updated Novavax COVID-19 Vaccine 
2023-10-03 20:09:18
by Dan McCue

WASHINGTON — The Food and Drug Administration on Tuesday amended its emergency use authorization for the Novavax COVID-19 vaccine, approving an updated version of the vaccine for use by previously vaccinated individuals aged 12 and older. Of course, those who... Read More

FDA Approves Marketing of DNA Test for Cancer Predisposition
Health
FDA Approves Marketing of DNA Test for Cancer Predisposition
2023-10-03 20:02:44
by Dan McCue

WASHINGTON — The Food and Drug Administration has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants associated with an elevated risk of developing... Read More

FDA Advisory Panel Concludes OTC Decongestant Doesn’t Work
Regulation
FDA Advisory Panel Concludes OTC Decongestant Doesn’t Work
2023-09-12 21:14:52
by Dan McCue

WASHINGTON — A common decongestant ingredient used in many popular over-the-counter medications simply doesn’t work, an advisory panel to the Food and Drug Administration said Tuesday, potentially setting the stage for a sweeping removal of many cold and flu remedies... Read More

FDA Approves Updated COVID Vaccines for New Variants 
Health
FDA Approves Updated COVID Vaccines for New Variants 
2023-09-11 19:35:37
by Dan McCue

WASHINGTON — The Food and Drug Administration on Monday approved the use of updated COVID-19 vaccines to provide the public with additional protection against the virus ahead of a potential winter bump in cases. One thing the FDA did not... Read More

FDA Approves First Over-the-Counter Birth Control Pill in US
Health
FDA Approves First Over-the-Counter Birth Control Pill in US
2023-07-13 13:41:47
by Dan McCue

WASHINGTON — The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription in the United States.  The agency’s approval of the over-the-counter medication this morning is a first, and is seen as... Read More

FDA Issues First Draft Guidance on Clinical Trials With Psychedelic Drugs
Health
FDA Issues First Draft Guidance on Clinical Trials With Psychedelic Drugs
2023-06-23 17:29:41
by Dan McCue

WASHINGTON — The Food and Drug Administration on Friday published a new draft guidance on what researchers should consider when investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders.  The first-of-its-kind... Read More

FDA Panel Endorses OTC Sale of Birth Control Pill
Women's Issues
FDA Panel Endorses OTC Sale of Birth Control Pill
2023-05-10 20:38:45
by Dan McCue

WASHINGTON — A panel of federal health advisors voted unanimously on Wednesday to approve the first over-the-counter sale of a medical contraceptive. The vote came at the end of a two-day meeting during which the panel, which offers nonbinding recommendations... Read More

FDA Authorizes New Injection Treatment for COVID-19
Regulation
FDA Authorizes New Injection Treatment for COVID-19
2023-04-05 17:55:23
by Dan McCue

WASHINGTON — The Food and Drug Administration on Tuesday issued an emergency use authorization for Gohibic (vilobelimab) injections to be used to treat COVID-19 in hospitalized adults. The authorization allows for the use of the injection within 48 hours of... Read More

Minnesota Suit Against E-Cigarette Maker Juul Goes to Trial
Health
Minnesota Suit Against E-Cigarette Maker Juul Goes to Trial

MINNEAPOLIS (AP) — Minnesota Attorney General Keith Ellison is slated to lead off opening statements expected for Tuesday in his state's lawsuit against Juul Labs – marking the first time any of the thousands of cases against the e-cigarette maker... Read More

Karuna Could Submit Schizophrenia Drug to FDA by Mid-Year
Business
Karuna Could Submit Schizophrenia Drug to FDA by Mid-Year
2023-03-20 20:55:40
by Dan McCue

BOSTON — Encouraged by positive topline results from its phase 3 trial for its new therapy for adults with schizophrenia, Karuna Therapeutics announced Monday that it is on track to submit KarXT to the Food and Drug Administration for approval... Read More

FDA Authorizes COVID Bivalent Booster for More Young Children
Health
FDA Authorizes COVID Bivalent Booster for More Young Children
2023-03-15 20:05:49
by Dan McCue

WASHINGTON — The Food and Drug Administration has amended its emergency use authorization of the Pfizer-BioNTech COVID-19 Bivalent vaccine, authorizing its use as a single booster dose for children 6 months through 4 years who’ve completed their primary vaccinations with... Read More

Bipartisan Bills Seek to Overhaul FDA Opioid Regulations
Prescription Drugs
Bipartisan Bills Seek to Overhaul FDA Opioid Regulations
2023-03-01 20:12:09
by Dan McCue

WASHINGTON — Sens. Joe Manchin, D-W.Va., and Mike Braun, R-Ind., reintroduced a trio of bills Wednesday aimed at reforming how the Food and Drug Administration approves and manages opioid medications. “In the last year, more than 106,000 Americans and 1,400... Read More

Advisory Panel Endorses Pfizer RSV Vaccine for Older Adults
Health
Advisory Panel Endorses Pfizer RSV Vaccine for Older Adults
2023-03-01 18:53:15
by Dan McCue

WASHINGTON — A panel of advisors to the Food and Drug Administration narrowly voted on Tuesday to endorse an experimental vaccine from Pfizer to protect older adults against the highly contagious lower respiratory tract ailment RSV. The advisors voted 7-4... Read More

FDA to Allow Retail Pharmacies to Offer Abortion Pills
Health
FDA to Allow Retail Pharmacies to Offer Abortion Pills
2023-01-04 15:22:54
by Dan McCue

WASHINGTON — An abortion pill previously available only from a certified doctor, clinic or two online pharmacies will soon be obtainable at local pharmacies with a prescription, the Food and Drug Administration announced Tuesday. Mifepristone is the first of two... Read More

Probe: Alzheimer’s Drug Approval ‘Rife With Irregularities’
Health
Probe: Alzheimer's Drug Approval 'Rife With Irregularities'

WASHINGTON (AP) — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA... Read More

FDA Panel Shoots Down Cytokinetics  Bid for Second Heart Drug Approval
Regulation
FDA Panel Shoots Down Cytokinetics Bid for Second Heart Drug Approval
2022-12-14 18:51:57
by TWN Staff

WASHINGTON — A panel of advisors to the Food and Drug Administration on Tuesday declined to recommend approval of a new heart drug created by biotech firm Cytokinetics, finding the benefits of the drug do not outweigh its risks. The... Read More

FDA Approves Bivalent COVID-19 Vaccines for Children as Young as 6 Months
Health
FDA Approves Bivalent COVID-19 Vaccines for Children as Young as 6 Months
2022-12-08 15:37:13
by Dan McCue

WASHINGTON — The Food and Drug Administration on Thursday amended its emergency use authorizations for the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines, saying the shots are safe to administer to children as young as 6 months old. “More children... Read More

Speedier Drug Approvals Hit Slowdown as FDA Faces Scrutiny
Health
Speedier Drug Approvals Hit Slowdown as FDA Faces Scrutiny

WASHINGTON (AP) — Expedited drug approvals slowed this year as the Food and Drug Administration's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in... Read More

FDA Conditionally Approves First Drug to Manage Acute Pancreatitis in Dogs
Regulation
FDA Conditionally Approves First Drug to Manage Acute Pancreatitis in Dogs
2022-11-17 13:50:24
by Dan McCue

WASHINGTON — The Food and Drug Administration has conditionally approved Panoquell-CA1 for the management of clinical signs associated with acute onset of pancreatitis in dogs.  Panoquell-CA1 is an injectable drug intended for use while the dog is hospitalized for treatment... Read More

FDA, Veterans Health Administration Partner to Accelerate Medical Device Innovation
Health
FDA, Veterans Health Administration Partner to Accelerate Medical Device Innovation
2022-09-28 19:27:00
by Dan McCue

WASHINGTON — The Food and Drug Administration and the Veterans Health Administration have entered into a new level of collaboration intended to help accelerate American medical device innovation.  Under the auspices of a memorandum of understanding signed last week, the... Read More

FDA Panel Backs Much-Debated ALS Drug in Rare, 2nd Review
Health
FDA Panel Backs Much-Debated ALS Drug in Rare, 2nd Review

WASHINGTON (AP) — A panel of federal health advisers voted Wednesday to recommend approval for an experimental drug to treat Lou Gehrig’s disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The... Read More

FDA Gives Millions of Americans Access to Over-the-Counter Hearing Aids
In The News
FDA Gives Millions of Americans Access to Over-the-Counter Hearing Aids
2022-08-16 14:16:55
by Dan McCue

WASHINGTON — The Food and Drug Administration issued a final rule Tuesday morning that promises to provide millions of Americans with access to lower cost, over-the-counter hearing aids. The action, which follows an executive order signed by President Joe Biden... Read More

FDA Approves COVID Vaccines for Children Aged 5 and Younger
Health
FDA Approves COVID Vaccines for Children Aged 5 and Younger
2022-06-17 15:56:33
by Dan McCue

WASHINGTON — The Food and Drug Administration on Friday gave its approval for COVID-19 vaccines for children age 5 and younger.  The shots could start as early as next week if, as expected, the Centers for Disease Control and Prevention... Read More

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