CBS Is 'First Major Network' to Tackle Suppression of COVID Vax Injuries by Biden FDA
CBS was given a shout-out by Sen. Ron Johnson for allowing him air time to talk about the dark side of the COVID vaccine.
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FDA Accepts Vertex's BLA for Povetacicept in IgA Nephropathy
VRTX moves closer to a potential nephrology launch as the FDA accepts its BLA for povetacicept in adults with IgAN, with a decision due in November 2026.
FDA Grants Priority Review to Roche's Early-Stage Breast Cancer NDA
RHHBY's giredestrant as an adjuvant treatment for early-stage breast cancer won FDA Priority Review, backed by encouraging phase III data versus standard therap...
Is Cognition Therapeutics, Inc. (CGTX) Moving Closer to a Registrational Trial in Dementia With Lewy Bodies?
TheFly reported on May 21 that CGTX held a planned regulatory meeting with the U.S.
FDA Grants Fast Track Designation to Merakris’ MTX-001, Opening Potential Accelerated Path to Market for Venous Leg Ulcer Therapy
Fast Track Designation Provides Opportunities for Rolling BLA Review, Enhanced FDA Engagement, and Earlier Alignment on Manufacturing and Regulatory Requirement...
FDA delays cost Americans trillions and slow lifesaving drugs, new report says
A new report estimates that speeding up FDA drug approval timelines by just one year could generate more than $10 trillion in economic value for consumers and p...
Nouscom Receives U.S. FDA Fast Track Designation for NOUS-209, a Novel Immunotherapy for the Prevention of Lynch Syndrome-Associated Cancers
Fast Track Designation (FTD) recognizes NOUS-209’s potential to address a serious condition with significant unmet medical need in Lynch Syndrome (LS) carrier...
Kamada Announces FDA Approval of its New In-House Rabies Virus Neutralization Testing Laboratory
REHOVOT, Israel and HOBOKEN, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfo...
As a physician, I know we need to focus on helping the forgotten smoker
Former HHS secretary shares how losing his father to smoking shaped his call for the FDA to address the 25 million forgotten smokers still at risk in America.
China's Original Innovative Drug Cipepofol Approved for Marketing by the U.S. FDA
BEIJING, June 1, 2026 /PRNewswire/ -- Cipepofol (CYPSEDO) Injection (hereinafter 'Cipepofol'), a Class 1 innovative intravenous anesthetic independently develo...
USFDA moots ways to reduce animal testing for cancer drugs
USFDA recommendations for reducing animal testing for cancer drugs
FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
Streamlined approach could reduce time and cost to bring new cancer drugs into human trials
Why regulatory rigour is becoming a competitive edge in clinical AI
AI may promise less paperwork and faster workflows, but healthcare organizations want clearer answers about privacy, reliability, and accountability.
US Food and Drug Administration Shifts to AI-Enhanced Regulatory Review With Elsa 4.0 and HALO
The US Food and Drug Administration recently announced the launch of Elsa 4.0 and Harmonized AI and Lifecycle Operations for Data (HALO)—an upgrade to its art...
MannKind Announces FDA Approval of Afrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabetes
MannKind Announces FDA Approval of Afrezza®, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with Diabe...
SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
SEOUL, South Korea, May 29, 2026 /PRNewswire/ -- South Korea-based medtech innovator SKIA has announced that the U.S. Food and Drug Administration (FDA) has gr...
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.
Gilead (GILD) Wins FDA Approval for First HDV Treatment Hepcludex
On May 22, 2026, the U.S. Food and Drug Administration approved Hepcludex injection, granted to Gilead Sciences, Inc.
FDA panel recommends updating Covid shots to target XFG strain
A Food and Drug Administration advisory panel on Thursday recommended updating this fall’s Covid shots to target the XFG variant, a fast-growing strain nickna...
FDA Publishes 2025 NYTS Raw Data; ACHE Concludes Smart Regulation Outperforms Bans in Curbing Youth Tobacco Use
FDA Publishes 2025 NYTS Raw Data; ACHE Concludes Smart Regulation Outperforms Bans in Curbing Youth Tobacco Use
Enterome receives U.S. FDA Orphan Drug Designation for EO2463 OncoMimics™ to treat "watch-and-wait” indolent non-Hodgkin lymphoma
Orphan Drug Designation confers regulatory, financial and strategic advantagesEO2463 has shown potentially disease modifying activity in clinical testing in wat...
Press Release: Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease
Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease
Inside The FDA's "Cover-Up" Of Child Deaths Linked To Covid Vaccines
ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero
Popsicles recalled because of undeclared allergens, dyes
De Dios’s Ice Pops II LLC is recalling its 3.7 oz. packages of “popsicles” because they may contain undeclared milk, yellow #5, red #40, pecans and pistachios. People who have an allergy or severe sensitivity to these ingredients run the risk of serious or life-threatening allergic reactions if
Abbott (ABT) Wins FDA and EU Approval for an AI-Powered Tool That Guides Artery Stent Placement
Abbott Laboratories (NYSE:ABT) is one of the best medical technology stocks to buy right now.
From Science to Practice: Senzime Obtains FDA 510(k) Clearance for Enhanced TetraGraph System
Senzime (STO:SEZI)(OTCQX:SNZZF) - Senzime AB today announced that its TetraGraph® neuromuscular monitoring system has received an additional FDA Class II 510(k...