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About 13,066 results

FDA Reviewers: Why We Are Against Approval of Aducanumab for Alzheimer's
https://www.medscape.com/viewarticle/950565

May 4th, 2021 - Three members of a US Food and Drug Administration (FDA) advisory committee are explaining why they do not support approval of the drug aducanumab (Biogen, Eisai) for the treatment of Alzheimer's disease (AD). G. Caleb Alexander, MD, Scott Emerson, MD, PhD, and Aaron Kesselheim, MD, JD, MPH, all serve on the FDA's Peripheral and Central Nervous System Advisory Committee and participated in the ...

Biden Wants 70% of the US Vaccinated by July 4
https://www.medscape.com/viewarticle/950597

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. President Joe Biden has announced new strategies for the national COVID-19 vaccination program as demand for vaccinations drops. He also set a new goal for getting shots into people's arms. "Our goal by July Fourth is to have 70% of adult Americans with at least one shot and 160 million American...

FDA Set to OK Pfizer Vaccine in Younger Teens
https://www.medscape.com/viewarticle/950430

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...

FDA OKs Higher-Dose Naloxone Nasal Spray for Opioid Overdose
https://www.medscape.com/viewarticle/950334

May 2nd, 2021 - The US Food and Drug Administration (FDA) has approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray. When a...

Some NP Thyroid Lots Recalled Due to Reduced Potency
https://www.medscape.com/viewarticle/950425

May 2nd, 2021 - In its third voluntary recall in the past year, Acella Pharmaceuticals has announced a nationwide recall of specific lots of its popular hypothyroid treatment NP Thyroid tablets USP, this time after routine testing found the pills to be subpotent. Specifically, the affected lots were found to contain less than 90% of the drug's two labeled ingredients to treat hypothyroidism: liothyronine (LT3)...

Recall: Hand Sanitizers May Contain Toxic Methanol
https://www.medscape.com/viewarticle/950293

Apr 29th, 2021 - Nearly a dozen scented hand sanitizer sprays sold at Ulta, TJ Maxx, and Marshalls stores nationwide are being recalled because they may be contaminated with methanol, a chemical that can be toxic when absorbed through the skin. Scentsational Soaps & Candles recalled the products after tests found methanol (wood alcohol), benzene, and acetaldehyde in some of its products, the company said in a s...

US Lawmakers Introduce 8 Antitrust Bills Aimed at Drug Prices
https://www.medscape.com/viewarticle/950229

Apr 29th, 2021 - WASHINGTON (Reuters) - U.S. lawmakers from both parties and both houses of Congress have introduced eight antitrust bills aimed at tackling the problem of high and rising drug prices, including bills to stop brand name drug companies from paying generic firms to stay off the market. In an unusual hearing of the House Judiciary Committee's antitrust panel on Thursday, lawmakers from both parties...

FDA Approves Dapagliflozin (Farxiga) for Chronic Kidney Disease
https://www.medscape.com/viewarticle/950329

Apr 29th, 2021 - The US Food and Drug Administration (FDA) has approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk for kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) at risk for disease progression. "Chronic kidney disease is an important public health issue, and there is a significant unmet ne...

FDA Panel Votes Against Two Cancer Indications but Backs 4 of 6
https://www.medscape.com/viewarticle/950247

Apr 29th, 2021 - Federal advisers this week supported the efforts of pharmaceutical companies in 4 of 6 cases in which these firms are fighting to maintain cancer indications for approved drugs. They voted against them in two cases. The staff of the US Food and Drug Administration (FDA) will now consider these votes as they decide what to do regarding the six cases of what they have termed "dangling" accelerate...

Once-Nightly Sodium Oxybate Agent Effective in Narcolepsy
https://www.medscape.com/viewarticle/950256

Apr 29th, 2021 - A novel, once-nightly formulation of sodium oxybate is safe and effective for treating both subjective and objective symptoms of narcolepsy, new research suggests. Top-line results from the phase 3 REST-ON trial released earlier this year showed that the agent known as FT218 (Avadel Pharmaceuticals) met all three of its co-primary efficacy endpoints at all three doses assessed (6 g, 7.5 g, and ...

New York Opens Probe Into Toxic Metals in Baby Food
https://www.medscape.com/viewarticle/950228

Apr 29th, 2021 - NEW YORK (Reuters) - New York's attorney general said on Thursday she has opened a probe into whether baby food contains arsenic and other toxic metals, and asked four manufacturers to provide information on whether their infant rice cereal products are safe. In letters to Nestle's Gerber, Beech-Nut Nutrition, Earth's Best Organic maker Hain Celestial Group and Happy Family Organics maker Nurtu...

FDA Moves to Ban Menthol in Tobacco Products
https://www.medscape.com/viewarticle/950223

Apr 28th, 2021 - The US Food and Drug Administration (FDA) has announced that within a year it will ban menthol in cigarettes as well as all flavors including menthol in cigars. Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, said the FDA in a statement Thursday. Nineteen organizations — including the American Academy of Pediatric...

Novavax's COVID-19 Vaccine May Be Authorized Next
https://www.medscape.com/viewarticle/950186

Apr 28th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Novavax's COVID-19 vaccine may be the next shot to receive emergency authorization in the U.S., according to Politico. The company is preparing to file the FDA paperwork in coming weeks and could beat out other vaccine manufacturers such as AstraZeneca. Public health officials and researchers se...

AHA Guidance on Blood Clots Linked to COVID-19 Vaccine
https://www.medscape.com/viewarticle/950231

Apr 28th, 2021 - A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus. The report was released today by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision last Friday by the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) to ...

To Stay: Two More Cancer Indications With 'Dangling Approvals'
https://www.medscape.com/viewarticle/950165

Apr 28th, 2021 - Two more cancer indications that had been granted accelerated approval by the US Food and Drug Administration (FDA) are going to stay in place, at least for now. This was the verdict after the second day of a historic 3-day meeting (April 27–29) and follows a similar verdict from day one. Federal advisers so far have supported the idea of maintaining conditional approvals of some cancer indicat...

US Probing Two New Blood Clot Cases After J&J's COVID-19 Vaccine
https://www.medscape.com/viewarticle/950016

Apr 27th, 2021 - (Reuters) - Two new cases of blood clots after administration of Johnson & Johnson's single-dose COVID-19 vaccine are being investigated by federal health officials, the U.S. Centers for Disease Control and Prevention said on Tuesday. One case was in a male and the other was in a female, both of whom were below 60 years, according to the agency, taking the total number of confirmed such cases t...

FDA Panel Backs Atezolizumab for mTNBC -- at Least for Now
https://www.medscape.com/viewarticle/950108

Apr 27th, 2021 - On the first day of a historic three-day meeting into cancer indications that were granted an accelerated approval by the Food and Drug Administration (FDA), the first one to come under discussion is staying in place, at least for now. Members of the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 7-2 in favor of keeping in place the indication for atezolizumab (Tecentriq) for use in a ce...

Want COVID Under Control? Screen Asymptomatic Kids Now, Fast
https://www.medscape.com/viewarticle/949849

Apr 27th, 2021 - Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. This transcript has been edited for clarity. Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I'm Dr F. Perry Wilson of the Yale School of Medicine. As we face a new struggle to get COVID-19 vaccination rates up in this country, we need to remember that there is a group of peopl...

US to Share Up to 60 Mln AstraZeneca Vaccine Doses Globally: White House
https://www.medscape.com/viewarticle/949981

Apr 26th, 2021 - WASHINGTON (Reuters) - The United States will start to share up to 60 million doses of AstraZeneca Plc's coronavirus vaccine with other countries as soon as the next few weeks, the White House said on Monday. White House Press Secretary Jen Psaki said the United States would release the doses to other countries as they become available. She said there could be 10 million doses cleared for expor...

Potential First-in-Class Schizophrenia Drug Cuts Negative Symptoms
https://www.medscape.com/viewarticle/950059

Apr 26th, 2021 - The novel antipsychotic agent SEP-363856 (Sunovion Pharmaceuticals) has a significant and ongoing effect on negative symptoms in patients with schizophrenia, new research shows. Results of a phase 2 placebo-controlled trial show SEP-363856 significantly decreased total scores on the Brief Negative Symptom Scale (BNSS), and lowered subscale scores for such symptoms as alogia and asociality, comp...