FDA Panelists Slam Agency's Proposed Opioid Trial Design Advisors said outcomes from an enriched enrollment study would not be broadly generalizable Apr 20, 2023
Antibody-Drug Conjugate Gets FDA Thumbs Up for Untreated DLBCL Adding polatuzumab vedotin to a modified version of R-CHOP significantly improved PFS Apr 20, 2023
FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain Agency advisors will consider pros, cons of an enriched enrollment randomized withdrawal design Apr 17, 2023
FDA Advisors Endorse Rexulti for Agitation in Alzheimer's Dementia Increased mortality risk seen but benefits may outweigh this, panelists say Apr 14, 2023
FDA Panel to Weigh Limited Data on Combo for Healthcare-Acquired Pneumonia Sulbactam-durlobactam under consideration for cases caused by Acinetobacter spp. Apr 14, 2023
All Opioid Pain Meds to Get New Safety Warnings, FDA Says Updated labeling to include warning about opioid-induced hyperalgesia Apr 13, 2023
Rexulti Works for Agitation in Alzheimer's, Despite Risks, Says FDA Staff Increased mortality risk consistent with other antipsychotics in elderly dementia patients Apr 13, 2023
Reworked Philips CPAP, BiPAP Machines May Not Deliver Correct Therapy And some of the remediated breathing devices may not provide any treatment at all, FDA warns Apr 10, 2023
FDA Approval Authority in Jeopardy? TB Hits the Casino; Sen. Blumenthal's Surgery Health news and commentary from around the Web gathered by ľֱ staff Apr 10, 2023
FDA Yanks Only Preterm Birth Drug, Effective Immediately Months after advisors recommended Makena's approval be withdrawn, FDA announces final decision Apr 06, 2023
Mail-Back Envelopes Will Be Dispensed With Outpatient Opioid Scripts Strategy will provide another option to dispose of unneeded medications, FDA says Apr 03, 2023
Do Away With 'Lockout' Period in iPLEDGE, FDA Advisors Urge It's an "unduly high burden" on patients, says one advisory committee member Mar 29, 2023
Isotretinoin REMS Still Needed, but Its Burden Could Be Reduced, FDA Staff Says Report suggests ways to lighten documentation rules for prescribing the severe acne treatment Mar 27, 2023
FDA Greenlights First Drug for Rare Immunodeficiency Disease Activated PI3K-delta syndrome may have a new standard of care Mar 27, 2023
FDA Faults Next-Gen Olympus Duodenoscopes After demanding single-use devices, agency finds they have their own problems Mar 27, 2023
FDA: Watch for Joint Replacement Device Failure After Exactech Recall Revision surgery only recommended for patients with pain Mar 23, 2023
FDA Panel Supports Tofersen for Rare Genetic ALS In a first, agency advisors back neurofilament light as a surrogate endpoint Mar 23, 2023
FDA OKs Another PD-1 Inhibitor for Merkel Cell Carcinoma Retifanlimab produced responses in 52% of patients with untreated unresectable disease Mar 22, 2023
FDA Has Neglected Clinical Trial Transparency — Plus $45 Billion in Fines It's time for more aggressive enforcement of the law Mar 21, 2023
Investigational ALS Drug May Have Clinical Benefit, FDA Staff Says Neurofilament light will be evaluated as a surrogate endpoint in tofersen review Mar 20, 2023
FDA Allows Lower Risk Designation for Snuff Product The brand joins a limited few granted modified risk tobacco claims Mar 16, 2023
CDC, FDA Heads Fire Back at Ladapo Letter Califf and Walensky say Florida Surgeon General's VAERS analysis is "incorrect, misleading" Mar 13, 2023
FDA Panel Endorses New First-Line Lymphoma Regimen POLARIX trial supports a favorable risk-benefit profile for polatuzumab vedotin, ODAC members say Mar 10, 2023
First Bimodal Neuromodulation Device for Tinnitus Gets FDA Nod Ringing ears may get relief with sound and tongue stimulation Mar 08, 2023
Only Drug to Prevent Preterm Birth Set to Leave the Market Decision follows FDA advisory committee recommendation for withdrawal Mar 08, 2023
FDA Not Quite Sold on Polivy in Frontline Large B-Cell Lymphoma Regimen Ahead of ODAC meeting, agency reviewers suggest modest PFS results in POLARIX "raise uncertainty" Mar 07, 2023
FDA Mandate on Acetaminophen-Opioid Combinations Appeared Effective Hospitalizations for liver toxicity declined after FDA limited acetaminophen dose Mar 07, 2023
First Treatment Approved for Rare Neurodegenerative Disorder Omaveloxolone gets FDA nod for Friedreich's ataxia Mar 01, 2023
Omecamtiv Mecarbil for Heart Failure Turned Down by FDA End of the road for cardiac myosin activator Mar 01, 2023
FDA Issues Import Alert on 'Tranq' Drug Xylazine Drug will be under added scrutiny to make sure it's for "legitimate veterinary use," agency says Feb 28, 2023
A Ban on the Abortion Drug Mifepristone Is Looming A Texas lawsuit may be disastrous for effective abortion access and FDA's authority Feb 23, 2023
Over-the-Counter Naloxone Has the Power to Save Lives But removing barriers to access is an essential next step Feb 23, 2023
Alzheimer's Data Faked? Docs 'Groomed' to Overuse Devices; Orphan Drug Fight This past week in healthcare investigations Feb 22, 2023
FDA Approves First Treatment for Geographic Atrophy Secondary to AMD Pegcetacoplan reduced GA lesion growth by 22% over 24 months versus sham injections Feb 18, 2023
FDA OKs First Therapy for Alpha-Mannosidosis Velmanase alfa approved for treating non-CNS manifestations of progressive, inherited disease Feb 17, 2023
Proposed User Instructions for OTC Narcan Has FDA Concerned In emergency setting, proper use and administration by consumer is "essential," says agency staff Feb 14, 2023
What Happened to the Monoclonal Antibodies for COVID-19? Losing focus on monoclonals means neglecting those who need them most: the immunocompromised Feb 13, 2023 video
FDA Warns on Use of Hospira Drug in Kids Due to 'Unsafe' Aluminum Levels Agency cites risk for aluminum toxicity in infants Feb 10, 2023
FDA Has Concerns on 'Unprecedented' Plan for Dostarlimab in Rectal Cancer Panel will discuss if single-arm trials and proposed endpoints are adequate to support approval Feb 08, 2023
