Topic: FDA
197 results were found.
New Alzheimer's treatment approved by FDA - July 5, 2024
Roche receives FDA approval for first molecular test to screen for malaria in blood donors - March 27, 2024
FDA warns against cinnamon products for elevated lead levels after poisoning in young children - March 8, 2024
U.S. FDA warns using smartwatches to measure blood glucose - February 23, 2024
WuXi Advanced Therapies receives FDA approval to manufacture Iovance's AMTAGVI (lifileucel) for advanced melanoma - February 21, 2024
FDA approves Xolair as first and only medicine for children and adults with one or more food allergies - February 19, 2024
FDA approves first medication to treat severe frostbite - February 15, 2024
AstraZeneca gets FDA green light for nerve disease treatment - December 22, 2023
FDA warns about recalled eye drops from India due to safety concerns - November 16, 2023
FDA approves first chikungunya vaccine from French company Valnev - November 10, 2023
Ultimovacs receives FDA orphan drug designation for UV1 cancer vaccine for treatment of mesothelioma - October 10, 2023
FDA to 8 companies: Stop selling unapproved eye products - September 13, 2023
FDA approves first vaccine for pregnant women to prevent RSV in infants - August 24, 2023
FDA warns Nuez de la India weight loss products appear to be highly toxic yellow oleander - August 20, 2023
FDA approves first oral medication for postpartum depression - August 7, 2023
FDA approves OTC naloxone nasal spray RiVive for opioid overdose - July 31, 2023
FDA approves purple tomato - July 24, 2023
FDA approves first nonprescription daily oral contraceptive - July 14, 2023
FDA converts novel Alzheimer's disease treatment to traditional approval - July 7, 2023
FDA approves Pfizer's hair loss drug - June 24, 2023
FDA permits marketing of first COVID-19 at-home test - June 7, 2023
FDA proposes new medication guide for patients - May 31, 2023
Musk's Neuralink receives FDA approval for human tests to connect brain and chips - May 27, 2023
FDA approves first oral antiviral for treatment of COVID-19 in adults - May 26, 2023
MedAlliance enrolls first U.S. patient into its third FDA IDE study: SFA SELUTION4SFA - May 5, 2023
FDA approves first RSV vaccine from GSK - May 4, 2023
Concept Medical received US FDA IDE approval for MagicTouch SCB in small vessel indication - May 2, 2023
FDA revokes approval of premature birth drug Makena - April 7, 2023
FDA approves first over the counter naloxone nasal spray - March 30, 2023
Vorasidenib granted fast track designation by FDA - March 14, 2023
FDA approves De Novo bimodal neuromodulation device to treat tinnitus - March 7, 2023
FDA accepts Valneva’s Chikungunya vaccine license application for priority review - February 20, 2023
FDA approves Orserdutm for patients with advanced or metastatic breast cancer - January 31, 2023
MTD Group: Innovative safety needle with fully passive mechanism, received FDA clearance - January 11, 2023
FDA approves new Alzheimer's drug that appears to slow illness - January 8, 2023
FDA grants priority review of glofitamab for lymphoma - January 8, 2023
AstraZeneca, Sanofi BLA for nirsevimab for respiratory syncytial virus accepted by FDA - January 6, 2023
FDA grants breakthrough designation for blood test to help diagnose inaccessible brain tumors - January 3, 2023
FDA approves new HIV drug for adults with limited treatment options - December 24, 2022
FDA approves Lunsumio to treat relapsed/refractory follicular lymphoma - December 24, 2022
FDA cautions horse owners not to feed recalled lots of Top of the Rockies alfalfa cubes due to illness and death - December 22, 2022
FDA approves Roche’s Actemra for treatment of COVID-19 in hospitalised adults - December 22, 2022
Pfizer and BioNTech apply for FDA authorization for Omicron-retooled vaccine booster in kids under 5 - December 6, 2022
Colorado submits Canadian drug importation plan to FDA - December 6, 2022
FDA bans Eli Lilly, Regeneron antibody use in COVID-19 patients infected by omicron - December 1, 2022
Roche receives FDA emergency use authorization for its high-throughput test to detect monkeypox virus - November 17, 2022
MedAlliance Selution SLR receives coronary FDA IDE approval - October 26, 2022
Roche receives FDA clearance for COVID-19 PCR test for use on cobas 6800/8800 Systems - October 24, 2022
FDA authorizes updated COVID-19 boosters for younger age groups - October 13, 2022
Lupin gets USFDA nod for HIV drug Darunavir - October 5, 2022
FDA approves Taiho's LYTGOBI (futibatinib) tablets - October 3, 2022
Pharming announces FDA acceptance for priority review of its new drug application for leniolisib - September 28, 2022
Pfizer and BioNTech submit application to FDA for emergency use of bivalent vaccine booster in children 5 to 11 - September 26, 2022
FDA: Do not give Mother's Touch Formula to infants - September 9, 2022
FDA authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 vaccines for use as booster dose - September 1, 2022
FDA approves first treatment for Acid Sphingomyelinase Deficiency, rare genetic disease - September 1, 2022
FDA to allow sale of hearing aids over the counter - August 17, 2022
FDA approves Roche's Xofluza to treat influenza in children aged 5 years and older - August 12, 2022
Menarini Group's Elacestrant granted priority review by FDA - August 12, 2022
MedAlliance SELUTION SLR receives second FDA IDE approval - August 11, 2022
FDA clears IND application for Phase I clinical study of tumor infiltrating lymphocyte therapy candidate - July 22, 2022
FDA authorizes Novavax COVID-19 vaccine for emergency use in adults - July 14, 2022
Perrigo's HRA Pharma submits application to FDA for first-ever OTC birth control pill - July 11, 2022
FDA authorizes pharmacists to prescribe Paxlovid with certain limitations - July 9, 2022
FDA grants full approval to Pfizer COVID vaccine for ages 12-15 - July 9, 2022
Pfizer announces submission of new drug application to FDA for Paxlovid - July 1, 2022
Menarini Group and Radius Health submit new drug application to the U.S. FDA for Elacestrant - June 25, 2022
Pfizer-BioNTech COVID-19 vaccine receives FDA the EUA for children 6 months through 4 years of age - June 18, 2022
FDA efforts to result in millions of additional bottles of infant formula - May 30, 2022
FDA authorizes Pfizer COVID-19 booster for children ages 5 to 11 - May 18, 2022
FDA encourages importation of safe infant formula - May 17, 2022
FDA limits use of Johnson & Johnson COVID-19 vaccine over blood clot risk - May 6, 2022
Abbott gets FDA clearance for test detecting 4 sexually transmitted infections - May 5, 2022
Roche says FDA grants priority review to Actemra for COVID-19 - April 4, 2022
FDA approves second booster of Pfizer, Moderna vaccines for 50 and over - March 29, 2022
Pfizer, Moderna seek FDA's authorization for second COVID booster shots - March 19, 2022
FDA permits marketing of first condom specifically indicated for anal intercourse - February 24, 2022
FDA: 404 stores Family Dollar stores got rodent contaminated products - February 19, 2022
FDA investigates Abbott's powdered infant formula after death reported - February 18, 2022
Datar Cancer Genetics early-stage prostate cancer detection blood test gets FDA grants - February 15, 2022
FDA deregulates making of French dressing - January 13, 2022
FDA clears Pfizer's COVID-19 booster shot for 12- to 15-year-olds - January 3, 2022
FDA authorizes first antiviral pills for COVID-19 - January 1, 2022
Roche COVID-19 home test granted FDA emergency use authorization - December 25, 2021
FDA authorizes another oral antiviral for COVID-19 treatment - December 24, 2021
Pfizer receives FDA emergency use authorization for novel COVID-19 oral antiviral treatment - December 22, 2021
FDA approves first injection regimen for HIV prevention - December 22, 2021
FDA authorizes Pfizer BioNTech coronavirus booster for ages 16, 17 - December 10, 2021
FDA grants emergency use for AstraZeneca's COVID-19 preventative - December 9, 2021
FDA grants designation for early stage breast cancer detection blood test by Datar Cancer Genetics - November 20, 2021
FDA advisors recommend authorizing Pfizer COVID-19 vaccine for children ages 5 to 11 - October 27, 2021
Applied DNA submits request for emergency use authorization to FDA for Linea SARS-CoV-2 Mutation Panel - October 25, 2021
FDA recommends Moderna's COVID-19 vaccine booster for at-risk adults - October 16, 2021
FDA recommends booster doses of Johnson & Johnson's COVID-19 vaccine - October 16, 2021
FDA issues food industry guidance for voluntarily reducing sodium in processed and packaged foods - October 14, 2021
FDA OKs COVID-19 booster shot for people 65 and older, or at high risk - September 23, 2021
FDA panel rejects call for third Pfizer booster shot - September 19, 2021
FDA says robust safety data needed before COVID-19 vaccine approval for kids - September 10, 2021
FDA declines emergency use approval for Humanigen's COVID-19 drug - September 9, 2021
U.S. FDA seeks new warnings on drugs from Pfizer, Lilly and AbbVie - September 2, 2021
FDA approves Comirnaty, first COVID-19 brand name approved in U.S. - August 26, 2021
FDA approves first COVID-19 vaccine - August 23, 2021
FDA OKs 3rd dose of COVID-19 vaccines for immunocompromised people - August 14, 2021
FDA okays Regeneron COVID-19 antibody as preventive in high-risk settings - July 31, 2021
FDA authorizes drug for treatment of hospitalized COVID-19 patients - June 25, 2021
BioVaxys receives positive FDA response for Pre-IND review for CoviDTH clinical development - June 15, 2021
FDA extends shelf life of Johnson & Johnson COVID-19 vaccine amid expiration controversy - June 11, 2021
FDA continues to ensure safety and effectiveness of authorized COVID-19 vaccines - April 23, 2021
Eli Lilly is seeking an EUA for bamlanivimab and etesevimab together from FDA as COVID treatment - April 16, 2021
U.S. advocacy groups: FDA should regulate genetically engineered animals - April 12, 2021
Whistleblower: FDA didn't react to blood, urine and feces in Merck facility - April 3, 2021
FDA approves first cell-based gene therapy for adult patients with multiple myeloma - March 29, 2021
FDA approves Johnson & Johnson's one-shot COVID-19 vaccine for emergency use - February 28, 2021
FDA approves storing Pfizer vaccines in standard freezers - February 26, 2021
FDA finds Johnson & Johnson's single-shot COVID-19 vaccine safe - February 25, 2021
FDA warns 10 companies for illegally selling dietary supplements - February 23, 2021
Pfizer and BioNTech submit COVID-19 vaccine stability data at standard freezer temperature to FDA - February 20, 2021
Indian cancer drug manufacturer to pay $50 million for destroying records before FDA inspection - February 10, 2021
Johnson & Johnson asks FDA to authorize COVID vaccine - February 5, 2021
FDA issues emergency use authorization for first U.S. coronavirus vaccine - December 12, 2020
Roche receives FDA emergency use authorization for new test to measure of coronavirus antibodies - December 2, 2020
AstraZeneca coronavirus vaccine trials resumed as FDA confirms safety - October 24, 2020
Mexico will not follow FDA in approving Gilead's coronavirus drug - October 24, 2020
FDACS identifies presence of invasive horntail snail in Florida - October 14, 2020
AG Racine urges FDA to stop Orange Book listings that prevent consumers from accessing drugs - September 9, 2020
FDA chief apologizes: Plasma treatment is not so good - August 27, 2020
FDA reiterates warning about dangerous alcohol hand sanitizers containing methanol - July 28, 2020
FDACS encourages horse community to be vigilant of Eastern Equine Encephalomyelitis - July 22, 2020
FDA: Toxic hand sanitizers have blinded and killed people - July 7, 2020
USDA, FDA strengthen U.S. food supply chain protections - May 21, 2020
Roche coronavirus antibody test receives FDA Emergency Use Authorization - May 5, 2020
CBP officers in El Paso seize non-FDA compliant thermometers - April 16, 2020
Lieutenant Governors Urge FDA to lift discriminatory ban on blood donations - April 14, 2020
FTC, FDA send warning to firms for products that can allegedly treat or prevent Wuhan coronavirus - March 10, 2020
FDA approves first treatment for peanut allergy - February 4, 2020
FDA approves first Ebola vaccine - December 21, 2019
FDA: Salmonella resistance increased - November 27, 2019
FDA warned Dollar Tree stores for receiving potentially unsafe drugs - November 18, 2019
FDA warns drug maker about inadequate quality control - August 22, 2019
FDA got 127 reports of seizure related to e-cigarettes, severe lung injury cases in Minnesota - August 15, 2019
FDA suspends facility of Texas-based seafood producer after repeated food safety violation - July 23, 2019
FDA: Homeopathic products are risk, we didn't approve them - May 14, 2019
FDA's Marks: It deeply concerns us when we see preventable diseases reemerging - April 23, 2019
FDA approves first generic naloxone nasal spray to treat opioid overdose - April 20, 2019
Exports of Indian shrimps come under US FDA scanner for antibiotics use - March 15, 2019
FDA finds asbestos in Claire's cosmetics, company doesn't care - March 6, 2019
FDA Commissioner: Epidemic use of e-cigarettes among children - February 12, 2019
FDA will ban many flavored e-cigarettes - November 13, 2018
FDA Commissioner Scott Gottlieb on launch of The Real Cost youth e-cigarette prevention campaign - September 19, 2018
FDA approves first generic version of EpiPen - August 16, 2018
FDA approves new vaginal ring for one year of birth control - August 11, 2018
FDA recalls medications used to treat high blood pressure over cancer concerns - July 16, 2018
FDA approves first drug for treatment of smallpox - July 14, 2018
FDA warns about stem cell therapies - June 4, 2018
FDA seeks permanent injunctions against two stem cell clinics - May 10, 2018
Family farm sues FDA for right to say skim milk is skim milk - April 13, 2018
FDA: Philip Morris iQOS device doesn't cut disease risk - January 25, 2018
FDA bans use of opioid-containing cough meds by kids - January 12, 2018
FDA system for treating pain without opioids - January 12, 2018
MFDA approves settlement with Sun Life Financial Investment Services Canada - December 21, 2017
FDA warns: Raw dough could make you sick - November 29, 2017
FDA OKs first 'biosimilar' drug to fight cancer - September 16, 2017
Novo Nordisk to pay $58m for failure to comply with FDA program - September 6, 2017
U.S. kids overdosing on dietary supplements, FDA can't do anything - July 27, 2017
FDA found salmonella in nearly 4% of pepper samples - July 3, 2017
Lifesaving drugs in short supply in U.S., says FDA - June 20, 2017
FDA OKs first cancer drug by genetic type, not organ of origin - May 26, 2017
Diabetes drug gets FDA warning due to amputation risk - May 19, 2017
FDA approves 1st new drug for ALS in decades - May 10, 2017
FDA takes action against 14 companies for selling illegal cancer treatments - April 26, 2017
FDA approves drugs that cure hepatitis C - April 11, 2017
Sugar Association to FDA: You want added sugar in sugar?! - March 30, 2017
FDA links breast implants to deaths, rare form of cancer - March 22, 2017
FDA urged to let abortion pill be sold at pharmacies - February 23, 2017
FDA warns: Belladonna found in homeopathic teething products - January 28, 2017
FDA warning letters for dairies and cheese factory - December 27, 2016
FDA warns of dangers from testosterone supplements - November 1, 2016
Medtronic recalls several devices, FDA notified - October 15, 2016
FDA approves first 'artificial pancreas' for type 1 diabetes - September 30, 2016
FDA warns ovarian cancer tests not reliable - September 13, 2016
FDA removes 'more harm than good' antibacterial soaps from market - September 5, 2016
FDA approves minimally invasive procedure for low back pain - July 28, 2016
FDA approves scalpel-free brain surgery to treat essential tremor - July 26, 2016
FDA warnings: From arsenic in juice to pathogens in meat - June 28, 2016
FDA approves AspireAssist obesity device - June 16, 2016
FDA sets new rules for food safety - May 30, 2016
FDA approves Micra, first wire-free pacemaker - April 11, 2016
FDA proposes limit for inorganic arsenic in infant rice cereal - April 1, 2016
FDA recalls Starbucks breakfast sandwiches over listeria fears - March 8, 2016
FDA warns of lead poisoning risk from cosmetic clay - February 2, 2016
Sun Pharmaceutical receives warning letter from FDA - December 21, 2015
FDA approves spray for painkiller and heroin overdoses - November 20, 2015
FDA approves first genetically engineered salmon - November 20, 2015
FDA: Custom Ultrasonics distributed medical devices without approval for years - November 17, 2015
FDA approves first 'female Viagra' - August 19, 2015
Insulet received warning letter from FDA - June 11, 2015
New FDA recommendations to ease blood donation rules for gay men - December 27, 2014