FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation - FDA Press Releases

The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.

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FDA approves first treatment for advanced form of the second most common skin cancer - FDA Press Releases

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

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Palliative Care and Geriatric Surgery - Geriatrics

Although many seniors cite maintaining independence and a desire to die at home as health priorities, admission to the ICU and the use of invasive procedures are common near the end of life. Palliative care aims to relieve pain and other symptoms to maintain the highest quality of life for the longest period of time, but surgical patients are less likely to be referred to palliative care than patients with chronic medical conditions. Meeting the palliative care needs of elderly surgical patients requires early recognition, advance care planning, and multidisciplinary interventions that align patient goals with possible outcomes.

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Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label - FDA Safety Alerts & Drug Recalls

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see picture below for location of incorrect text).

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FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma - FDA Press Releases

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

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Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models) - FDA Safety Alerts & Drug Recalls

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. In the last six years, a total of four serious injuries were reported to Oscor which were attributed to a connector cap malfunction causing the lead connector to separate during use potentially leading to an interruption of the pacing system.

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Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s role in preparing for flu season

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