Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to visible particulate Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial Company Announcement Hospira, Inc., a P...

Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to mislabeling Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and 1% Lidocaine HCl Injection, USP 30 mL Company Announcement Hosp...

May 4th, 2021 - For Immediate Release: May 04, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA Center for Drug Evaluation and Research (CDER) continually monitors our ability to meet user fee commitments. To maintain transparency during the COVID-19 public health emergency, CDER posts periodic updates to the...

May 4th, 2021 - For Immediate Release: April 28, 2021 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Janet Woodcock M.D. Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise. Across all ...

May 3rd, 2021 - The British Society of Gastroenterology has published new guidelines on the management of irritable bowel syndrome (IBS). Here's a summary of the key recommendations: Diagnosis The National Institute for Health and Care Excellence (NICE) guideline definition of IBS (abdominal pain or discomfort association with altered bowel habit for six months or more, in the absence of alarm symptoms or sign...

May 3rd, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The FDA could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency's plans. In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COV...

May 3rd, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic. Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers. The pandemic has been "an en...

May 3rd, 2021 - CARACAS (Reuters) - Venezuela this month will begin clinical trials of the Cuban coronavirus vaccine candidate Abdala, and plans to produce enough doses locally to vaccinate 4 million people, Health Minister Carlos Alvarado said on Monday. Cuba in March approved late-stage trials of Abdala, named after a poem by the 19th-century Cuban independence hero Jose Marti. The trials of the protein subu...

May 3rd, 2021 - SANTIAGO (Reuters) - The director of Chile's health regulator said he sees no evidence of safety issues with Sputnik V, the COVID-19 vaccine developed in Russia, despite its rejection by the Brazilian health regulator this week over a lack of information about its safety. Heriberto Garcia, the director of Chile's Public Health Institute (ISP), said Chile was seeking clarity from the vaccine's d...

May 3rd, 2021 - Loneliness among middle-aged men ups their risk of cancer, and being single at the time of diagnosis confers a worse prognosis, suggest results from a longitudinal Finnish study with a mean follow-up of 20 years. The study also found that although loneliness was associated with an increased risk of cancer, social isolation was not. It's not clear why loneliness had a stronger association with c...

May 3rd, 2021 - Dr William Stewart A large study of adolescent soccer players in Michigan revealed key differences in concussion injury metrics among males and females, underscoring a need to develop sex-specific approaches to managing injury in the sport. Sport-related concussion (SRC) is a specific concern in young female athletes, study authors Abigail C. Bretzin, PhD, and colleagues noted in their paper, w...

May 3rd, 2021 - (Reuters) - Over 60 U.S. stadiums and other venues are deploying an app from Clear to verify people's COVID-19 status, placing the New York company known for its airport security fast lanes at the forefront of a national debate over "vaccine passports." Major League Baseball's San Francisco Giants and New York Mets are among the first big businesses to demand guests prove they tested negative f...

May 3rd, 2021 - Lobaplatin-based induction plus chemoradiation was as effective as, and safer than, a cisplatin-based regimen in a phase 3 trial of more than 500 patients with advanced nasopharyngeal carcinoma. The lobaplatin regimen proved to be a "promising alternative regimen to cisplatin-based treatment," Xing Lv, MD, of Sun Yat-sen University Cancer Centre in Guangzhou, China, and colleagues wrote in The ...

May 3rd, 2021 - NEW DELHI (Reuters) - A forum of scientific advisers set up by the government warned Indian officials in early March of a new and more contagious variant of the coronavirus taking hold in the country, five scientists who are part of the forum told Reuters. Despite the warning, four of the scientists said the federal government did not seek to impose major restrictions to stop the spread of the ...

May 3rd, 2021 - BRUSSELS (Reuters) - The European Union's executive has recommended easing COVID-19 travel restrictions next month to let foreign travellers from more countries enter the EU, hoping to boost the stricken tourism industry this summer. Under current restrictions, people from only seven countries, including Australia and Singapore, can enter the EU on holiday, regardless of whether they have been ...

May 3rd, 2021 - Second-line treatment with sintilimab improved survival, when compared with docetaxel, in patients with advanced/metastatic squamous non–small cell lung cancer (sqNSCLC) in a phase 3 trial. Sintilimab improved both overall survival (OS) and progression-free survival (PFS), according to Yuankai Shi, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing. Shi pre...

May 3rd, 2021 - (Reuters) - Some COVID-19 survivors infected early in the pandemic still have detectable antibodies against the virus a year later, according to a new study. U.S. doctors collected blood samples from 250 patients, including 58 who had been hospitalized for COVID-19 and 192 who had not required hospitalization. Six-to-10 months after diagnosis, all of the former inpatients and 95% of the outpati...

May 3rd, 2021 - After spending much of the past year tending to elderly patients, doctors are seeing a clear demographic shift: young and middle-aged adults make up a growing share of the patients in covid-19 hospital wards. It's both a sign of the country's success in protecting the elderly through vaccination and an urgent reminder that younger generations will pay a heavy price if the outbreak is allowed to...

May 3rd, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The United States set another record for the number of air travelers since the pandemic set in, although passenger numbers remain far below 2019 levels. More than 1.6 million people were screened at US airport checkpoints on Sunday, according to the Transportation Security Administration. That w...

May 3rd, 2021 - For most vitamin and mineral supplements, there is not enough evidence to recommend for or against taking them to prevent cancer and cardiovascular disease (CVD), according to new draft recommendations from the US Preventive Services Task Force. While the evidence is still unclear for most vitamin and mineral supplements, there is evidence that two products do not reduce the risk of these disea...