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The Latest Breaking News from FDA

FDA to update regulations after unconfirmed claims of Covid vaccine-linked death

Announcement, and lack of details in the weeks following, represents major departure from previous FDA priorities

The Guardian - US

‘Not me JUST getting prescribed’: New Mexico woman takes commonly prescribed antibiotic. Then it puts her in a wheelchair, leaves her ‘fighting for my life’

A TikToker is warning against the unregulated use of a commonly prescribed antibiotic. According to her, it left her and others “fighting for [their] lives” because of adverse side effects.

The Mary Sue

Baby formula tied to botulism outbreak could have been in American stores since 2022 as massive recall continues

The infant botulism outbreak linked to ByHeart formula has expanded following the company’s full product recall last month

The Independent UK

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Cookie dough sold in 15 states recalled over salmonella concerns

The recall was updated December 5 to Class I

The Independent UK

This RFK Jr.-founded group demands the FDA kill the COVID vaccine

An anti-vaccine organization founded by Robert F. Kennedy Jr. filed a petition to remove the shots from the market.

Axios

‘Viagra’ for women hits the shelves – 30 years after men got little blue pills

The first-of-its-kind topical cream ‘DARE to PLAY’ will cost people $10 per use

The Independent UK

Texas and Florida sue FDA in latest effort to restrict abortion pill access

States’ attorneys general argue agency has failed to properly evaluate mifepristone’s safety since initial 2000 approval

The Guardian - US

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Fresh warning as baby formula botulism outbreak sickens more than 50 babies

Babies are vulnerable until about age 1 because their gut microbiomes are not mature enough to fight the toxin

The Independent UK

Tomato soup sold in 14 states under recall over allergy concerns

The product was recalled after a routine inspection, which found that consumption could cause a serious allergic reaction

The Independent UK

Eggs shipped to US stores and restaurants under recall for salmonella threat

The contamination was caused by the company’s processing equipment

The Independent UK

2026’s abortion battles will be fought more in courthouses and FDA offices than at the voting booth

In 2026, the biggest battles over abortion will not be at the polls.

The Conversation

US health officials re-examine RSV shots despite documented safety and efficacy

The FDA is reviewing RSV vaccines, which have drastically lowered infant hospitalizations, a spokesperson confirmed

The Guardian - US

FDA opens safety review of injectable RSV drugs approved for babies and toddlers

Federal health officials are reviewing the safety of two injectable drugs used to protect babies and toddlers from the RSV virus

The Independent UK

US recalls popular blood pressure medication over fears of cross-contamination with another drug

Samples of the pill ‘showed presence’ of another type of drug, the FDA said

The Independent UK

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Benzinga

Drugmakers Briefed As Vaccine Skeptics Like RFK Jr. Probe RSV Therapy Risks

U.S. regulators are taking a fresh look at infant respiratory syncytial virus (RSV) antibody treatments after concerns raised by vaccine skeptics prompted Robert F. Kennedy Jr.'s health leadership team to initiate new safety inquiries.

inkl

Ink & Regulation: How New Safety Laws Are Transforming the Global Tattoo Industry

Tattooing has moved from the fringes of culture to the center of mainstream identity. What used to be a subcultural expression is now a global, multibillion-dollar market shaped by professional studios, standardized hygiene protocols and increasingly sophisticated equipment.

Benzinga

Ocular Therapeutix Stock Skyrockets On Faster FDA Path For Vision Drug

Ocular Therapeutix Inc. (NASDAQ:OCUL) stock surged on Monday after the company announced plans to accelerate the timeline for submitting a New Drug Application (NDA) for Axpaxli (OTX-TKI) in the treatment of wet age-related macular degeneration (wet AMD).

Medical Daily

Stem Cell Therapy Uses: What Regenerative Medicine Can Treat—and the Stem Cell Risks to Know

Stem cell therapy uses are expanding in regenerative medicine, but risks and limits remain. Learn which conditions stem cells can treat safely and which remain experimental.

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inkl

Why Requirements Management Is Critical in Regulated Device Development

In the development of regulated medical devices, adherence to stringent regulatory requirements is not optional but a foundational necessity. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others around the world enforce strict guidelines to ensure the safety, efficacy, and reliability…

The Independent UK

Families of people killed in UPS cargo plane crash sue carrier for wrongful death

The crash in Kentucky of an MD-11 cargo plane killed 14 people and injured 23 others on November 4

Benzinga

Praxis' Epilepsy Drug Too Good To Continue, FDA Meeting Up Next

Praxis Precision Medicines Inc. (NASDAQ:PRAX) stock rose Friday after the company shared results from the registrational cohort of the EMBOLD study evaluating relutrigine for the treatment of patients with SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs).

Benzinga

Denali Flags Minimal Delay After FDA Halts Rare Disease Trial Start

The U.S. Food and Drug Administration (FDA) placed a clinical hold on Denali Therapeutics Inc.’s (NASDAQ:DNLI) investigational new drug (IND) application for the Phase 1 study of DNL952 under development for Pompe disease.

Benzinga

FDA Warns Against Abbott Glucose Monitor Sensors After Reports Of Over 700 Injuries, 7 Deaths

The U.S. Food and Drug Administration (FDA) in December issued a safety alert urging people with diabetes to stop using select glucose sensors made by Abbott Laboratories’ (NYSE:ABT) Diabetes Care, after the company linked the devices to seven deaths and hundreds of serious injuries.

Euronews

Faulty glucose monitors linked to 7 deaths and more than 700 injuries worldwide. Here’s what we know

The sensors provide real-time measurements of sugar levels in the blood, sending that data wirelessly to a device or phone.

inkl

Best 7 Pharmaceutical Filtration Solution Providers in 2025

Efficient filtration is the backbone of pharmaceutical manufacturing in 2025.

1 … 11 12 13 14

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