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About 15,843 results

Double the Pleasure: Stim Patch Delays Early Ejaculation: Study
https://www.medscape.com/viewarticle/974773

May 27th, 2022 - A wearable patch that delivers electrical stimulation to the perineum may postpone premature ejaculation, according to research presented at the 2022 annual meeting of the American Urological Association. The disposable device appears to work by helping men contract the muscles in the pelvic floor, allowing them to postpone climax. Among 34 men with a lifelong history of premature ejaculation, ...

The Next US Abortion Battle Is Over Pills, and It's Already Begun
https://www.medscape.com/viewarticle/974646

May 27th, 2022 - WASHINGTON (Reuters) - The U.S. Supreme Court has not yet released its decision that looks set to dramatically scale back abortion rights, but one of the next legal battles has already begun in a Mississippi court. That is where the manufacturer of a pill used to carry out medication abortions, Las Vegas-based GenBioPro Inc, has filed a federal lawsuit challenging the conservative state's restr...

Focus on Antivirals, Vaccines as Monkeypox Continues
https://www.medscape.com/viewarticle/974659

May 26th, 2022 - Since the first case of monkeypox on May 6, reports of outbreaks have come from multiple countries, with the UK, Spain, and Portugal in the lead, followed by Canada, Israel, and Australia, among others. The US has reported cases in Boston and New York City, and presumed cases have occurred in Utah and Florida. As of May 25, close to 350 cases, either suspected (83) or confirmed (265), have been...

Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors
https://www.medscape.com/viewarticle/974670

May 26th, 2022 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Novavax hitched its wagon to the global coronavirus pandemic. Before most Americans truly grasped the scope of the danger, the small Maryland biotech startup had secured $1.6 billion in U.S. funding for its covid vaccine. Its moonshot goal: delivering 2 billion shots to the world by mid-2021. Al...

Lawmakers Grill US FDA on Response to Abbott Baby Formula Safety
https://www.medscape.com/viewarticle/974634

May 26th, 2022 - WASHINGTON (Reuters) - Lawmakers grilled U.S. Food and Drug Administration officials on Wednesday over what they saw as a lack of urgency in the agency's response to complaints about possible baby formula contamination at a now shuttered Abbott Laboratories plant that led to severe nationwide shortages. FDA leaders appeared before a congressional panel to answer questions about the crisis after...

FDA Chief to Detail Delays Inspecting Baby Formula Plant
https://www.medscape.com/viewarticle/974595

May 25th, 2022 - WASHINGTON (AP) — Federal plans to inspect a baby formula factory linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and other logistical problems, according to prepared testimony from the head of the Food and Drug Administration. FDA Commissioner Robert Califf is set to answer questions Wednesday from House lawmakers probing the events leading to the formula shorta...

Manufacturer Announces FDA Approval for Molluscum Treatment Delayed
https://www.medscape.com/viewarticle/974608

May 25th, 2022 - The anticipated US Food and Drug Administration (FDA) approval of VP-102 for the treatment of molluscum contagiosum has been delayed because of deficiencies identified at a contract manufacturing organization, according to Verrica Pharmaceuticals, which is developing the product. VP-102 is a proprietary drug-device combination of cantharidin 0.7% administered through a single-use precision appl...

FDA Allows Import of 2 Million Cans of Baby Formula From UK
https://www.medscape.com/viewarticle/974618

May 25th, 2022 - The FDA is easing rules to allow infant formula imports from the U.K., which would bring about 2 million cans to the U.S. in coming weeks. Kendal Nutricare will be able to offer certain infant formula products under the Kendamil brand to ease the nationwide formula shortage. "Importantly, we anticipate additional infant formula products may be safely and quickly imported in the U.S. in the near...

FDA Chief Under Fire for Slow Response to Baby Formula Issue
https://www.medscape.com/viewarticle/974631

May 25th, 2022 - WASHINGTON (AP) — The head of the Food and Drug Administration faced bipartisan fury from House lawmakers Wednesday over months of delays investigating problems at the nation's largest baby formula plant that prompted an ongoing shortage. FDA Commissioner Robert Califf laid out a series of setbacks in congressional testimony that slowed his agency's response, including a COVID-19 outbreak at th...

FDA Approves Topical Tapinarof for Plaque Psoriasis
https://www.medscape.com/viewarticle/974539

May 24th, 2022 - The Food and Drug Administration has approved tapinarof cream, 1%, a steroid-free topical cream applied once a day, for the treatment of mild, moderate, or severe plaque psoriasis in adults, the manufacturer announced. Tapinarof is an aryl hydrocarbon receptor agonist and is the first FDA-approved steroid-free topical medication in this class, according to a press release from the manufacturer,...

US FDA Sets June Meeting Dates for Moderna, Pfizer Small Children COVID-19 Vaccines
https://www.medscape.com/viewarticle/974424

May 24th, 2022 - WASHINGTON (Reuters) - The U.S. Food and Drug Administration set June 14-15 as the new meeting date to review Moderna Inc's emergency authorization request for its COVID-19 vaccine for children aged 6 months to 5 years and Pfizer Inc's vaccine for those aged 6 months through 4 years. The new dates for our pediatric COVID-19 vaccine advisory committee meetings will now be June 14 and June 15, th...

Biohaven's Drug for Neurological Disease Fails Late-Stage Study
https://www.medscape.com/viewarticle/974435

May 24th, 2022 - (Reuters) - Biohaven Pharmaceutical said on Monday its experimental drug for patients with spinocerebellar ataxia, a genetic disease that affects the nervous system, failed to meet the main goal of a late-stage study. Spinocerebellar ataxia (SCA) is a progressive disorder caused by the degeneration of cells in the brain and spinal cord and can lead to symptoms such as uncoordinated movement and...

Pfizer Says COVID-19 Vaccine Response Robust in Young Children
https://www.medscape.com/viewarticle/974473

May 23rd, 2022 - Find the latest COVID-19 news and guidance in Medscape's  Coronavirus Resource Center. Pfizer/BioNTech today reported 80% efficacy with three doses of its COVID-19 vaccination for toddlers and children up to 5 years old The study of 1678 younger children was done when Omicron was the predominant variant. Pfizer plans to submit this new data to the US Food and Drug Administration (FDA) as part o...

FDA, AMA Prepare for Potential COVID Shots for Kids Younger Than 6
https://www.medscape.com/viewarticle/974483

May 23rd, 2022 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Regulators and the nation's largest physician organization took separate steps in recent days to prepare for expected authorization of use of COVID-19 vaccines in children younger than age 6. The US Food and Drug Administration (FDA) on Monday announced its Vaccines and Related Biological Produc...

Exploding E-Cigarettes Cause Traumatic Injuries in Teens
https://www.medscape.com/viewarticle/974404

May 23rd, 2022 - A study shows that over a 4-year period, 15 teenagers were injured from exploding e-cigarettes, according to surgeons who have treated young people at nine hospitals in the United States. "It definitely was an injury we were seeing frequently," Shannon Acker, MD, an assistant professor of pediatric surgery at the University of Colorado School of Medicine and a pediatric surgeon at Children's Ho...

FDA Approves First Drug for Eosinophilic Esophagitis
https://www.medscape.com/viewarticle/974374

May 20th, 2022 - The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron) to treat eosinophilic esophagitis (EoE) in adults and children aged 12 years and older weighing at least 40 kg. EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating. Dupilumab is a monoclonal antibody that acts to inhibit p...

Baricitinib Recommended for Approval of Severe Alopecia Areata in Europe
https://www.medscape.com/viewarticle/974368

May 20th, 2022 - The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of baricitinib, a Janus kinase (JAK) inhibitor, for the treatment of adults with severe alopecia areata (AA). The development, which was announced in a May 20, 2022, press release from the manufacturer, Eli Lilly and Incyte, marks the first step toward European regulatory approva...

Tirzepatide's Retail Price Set at About $12,666 Per Year
https://www.medscape.com/viewarticle/974390

May 20th, 2022 - Tirzepatide (Mounjaro) — the new twincretin approved by the US Food and Drug Administration (FDA) for glycemic control in patients with type 2 diabetes — was priced by Lilly, the company that will market the drug, at a list price of $974.33 for four weekly doses regardless of dose size, a cost that adds up to about $12,666 per year, according to a statement made on May 20 by a Lilly spokesperso...

Biden Uses Defense Production Act to Address Baby Formula Shortage
https://www.medscape.com/viewarticle/974309

May 19th, 2022 - President Joe Biden took steps on Wednesday to deal with the nationwide shortage of powdered baby formula.  He used the Defense Production Act to require suppliers to direct resources to baby formula makers before other customers, the White House said in a fact sheet. "Directing firms to prioritize and allocate the production of key infant formula inputs will help increase production and speed ...

FDA Declines to Authorize Common Antidepressant as COVID Treatment
https://www.medscape.com/viewarticle/974075

May 18th, 2022 - (Reuters) - The U.S. Food and Drug Administration has decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying that the data has not shown the drug to be an effective therapeutic for fighting the virus. "Based on the review of available scientific evidence, the FDA has determined that the data are insufficient to conclude that fluvoxamine may be effective in the treatme...