The hottest FDA Approval Substack posts right now

FDA approval of a drug does not mean it is completely without risks; it means the benefits are deemed worth the risks.
The FDA assesses the risks and benefits of a drug based on the research provided by the pharmaceutical company before granting approval.
When it comes to weight loss drugs, the risk/benefit analysis by the FDA may be skewed due to questionable research around weight and health, leading to a lower safety bar for approval.

Eli Lilly and other pharmaceutical companies are focused on lobbying for insurance coverage of weight loss drugs, pushing for the idea of higher-weight bodies as a 'disease' worth medicating.
The FDA approval for weight loss drugs like Zepbound requires different criteria based on BMI, raising concerns about the risk assessments being tied to body size.
Pharmaceutical companies like Eli Lilly prioritize shareholder interests over customer concerns, raising questions about the true motivations behind their actions.

Remdesivir, a controversial drug, was approved by the FDA for COVID treatment in kidney patients.
Family members of patients express anger and grief over the use of Remdesivir, linking it to worsened health conditions and deaths.
Financial incentives and hospital protocols played a significant role in the administration of Remdesivir, raising concerns about ethics and patient care.

There has been a resurgence of interest in the medical potential of psychedelics, with ongoing research and clinical trials exploring their efficacy in treating mental health conditions.
Despite the challenges and market fluctuations, there is increasing regulatory support for psychedelic drug trials, potentially leading to FDA approvals and breakthrough therapy designations for conditions like PTSD.
Psychedelic treatments involve controlled drug administration in conjunction with therapy, aiming to address the root causes of mental health disorders by stimulating new perspectives and thought patterns.

New FDA rules require medical device makers to meet specific cybersecurity criteria for approval.
Manufacturers must offer updates and patches for cybersecurity and develop a plan for addressing postmarket vulnerabilities.
Rules focus on devices connected to the internet, like insulin pumps and pacemakers, not legacy technology.

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Cognitive Behavioral Therapy for Insomnia is the best first-line treatment for insomnia.
Sleep medications can help with treatment-resistant insomnia but come with significant negative side effects and should not be used long term.
Benadryl and doxylamine are common over-the-counter sleep aids with safety and efficacy concerns, potential for anticholinergic side effects and long-term safety issues.

Novartis' combination Tafinlar + Mekinist received FDA approval for pediatric patients with low-grade glioma
The spotlight is on Day One Biopharmaceuticals with the approval
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Karuna Therapeutics reported positive data on the third trial for schizophrenia.
The company is well-positioned to win FDA approval with a planned NDA by mid-2023.
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Zepbound, a new weight loss drug, is approved by the FDA and competes with established drugs like Wegovy.
Zepbound may lead to a price war in the weight loss drug market, potentially resulting in lower prices for consumers.
Zepbound's unique combination of hormones helps with weight loss and Eli Lilly is already working on even more potent drugs in the future.