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STAT+: Experts critique flawed system for monitoring drugs’ side effects in wake of asthma drug report

STAT

and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address. Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. “The question is, how safe do you want to be?”

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FDA approves Regeneron’s Libtayo and chemotherapy combination for NSCLC

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals ’ PD-1 inhibitor Libtayo (cemiplimab-rwlc) and chemotherapy combination as the first-line treatment for advanced non-small cell lung cancer (NSCLC). Patients may receive this therapy regardless of PD-L1 expression or tumour histology.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

The FDA Law Blog

In 2006, FDA stated that DMCs were not recommended “for most clinical studies,” particularly those in early product development, short-term studies, or studies addressing less severe outcomes. Increased Connections Between a DMC and FDA? However, in contrast to DMCs, such an entity should remain blinded to efficacy data.

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Can you drink while taking clindamycin?

The Checkup by Singlecare

According to the drug’s FDA label , there is no known clindamycin and alcohol interaction. You definitely will want to avoid a night of binge drinking while on clindamycin. Drinking alcohol with the following antibiotics may lead to adverse reactions : Bactrim (sulfamethoxazole and trimethoprim).

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Important information about Dupixent and vaccines

The Checkup by Singlecare

Its most common use is for the treatment of severe eczema (atopic dermatitis) in adults and children 6 months and older, but it’s also approved by the Food and Drug Administration (FDA) to treat asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and eosinophilic esophagitis (EoE) in certain people.

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Does Ozempic cause blood clots?

The Checkup by Singlecare

“There is not enough evidence to say that semaglutide definitely causes blood clots,” says Jodie Pepin, Pharm.D. Additionally, the Food and Drug Administration (FDA) prescribing information for Ozempic does not mention blood clots as a possible adverse reaction. clinical pharmacy program director at Harbor Health.

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What is 5-HTP and Why Was It Banned?

BuzzRx

Although there is limited evidence supporting 5-HTP’s place in therapy for the listed conditions, 5-HTP definitely plays a role in a wide variety of health conditions caused by low serotonin levels. Food and Drug Administration (FDA) does not regulate supplements the same way they do with prescription medications.