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MONDAY, July 21, 2025 -- The U.S. Food and Drug Administration has approved a prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster). The existing vaccine consists of two.
THURSDAY, June 26, 2025 — Updated COVID-19 vaccines are keeping up with new coronavirus strains and remain effective for keeping people out of the hospital, a new study says. The study, which examined the effectiveness of the 2023-2024 COVID.
TUESDAY, June 10, 2025 — U.S. vaccine recommendations. Health and Human Services Secretary Robert F. Kennedy Jr. has removed all 17 members of the expert panel that makes U.S. Kennedy made the surprise announcement in an opinion piece.
FRIDAY, May 2, 2025 -- The U.S. Department of Health and Human Services and the National Institutes of Health announced a new initiative called "Generation Gold Standard" to develop next-generation, universal vaccines using a beta-propiolactone.
TUESDAY, June 3, 2025 -- The U.S. Food and Drug Administration has approved a new lower-dose vaccine for active immunization against COVID-19 caused by severe acute respiratory syndrome coronavirus 2. The new vaccine (mNexspike [COVID-19 Vaccine.
All nominations for the 2025 Merkin Prize were evaluated by a selection committee composed of nine scientific leaders from academia and industry in the US and Europe. The winners will be honored in a prize ceremony later this year.
By Broad Communications June 24, 2025 Credit: Casey Atkins David Liu is a core member at the Broad Institute where he is the Richard Merkin Professor and director of the Merkin Institute for Transformative Technologies in Healthcare. s mutation and may never be used to treat another person.
Published July 14, 2025 Ben Fidler Senior Editor post share post print email license Takeda reported positive results for oveporexton, a drug being developed for narcolepsy Type 1, on July 14, 2025. and elsewhere in its 2025 fiscal year and plans to present detailed results at an upcoming medical meeting. inhibitors.
It serves as the backbone for vaccines that have been deployed worldwide to prevent COVID-19 (Janssen, Vaxzevria, Sputnik V) and Ebola virus. When employed in vaccines, LNPs enter the muscle tissue, where they transfect local muscle and immune cells.
MONDAY, June 16, 2025 — Kidney damage is common during a severe case of COVID-19, but vaccination appears to protect people against this life-threatening side effect, a new study says. Unvaccinated COVID patients with kidney damage severe enough to.
ISSUE 44 — The Importance of Cytokine Release Assays to Derisk the Development of Immunomodulatory Drugs pmjackson Mon, 07/07/2025 - 21:31 New immunomodulatory drugs have the potential to cause serious immune-related adverse events, including cytokine release syndrome (CRS).
CDC panel backs long-acting monoclonal antibody to protect infants during their first RSV season; drug also included in federal Vaccines for Children program Merck , operating as MSD outside the United States and Canada, has announced a key regulatory milestone for its respiratory syncytial virus (RSV) prevention program. What Is ENFLONSIA™?
Sanofi Ramps Up Early Global Distribution of Beyfortus to Meet Growing RSV Season Demand, Enhancing Protection for Infants Worldwide In a proactive move to ensure readiness for the 2025-2026 respiratory syncytial virus (RSV) season, Sanofi has announced that shipments of Beyfortus® (nirsevimab) will begin in early Q3 2025.
Published June 11, 2025 Ben Fidler Senior Editor post share post print email license The FDA on June 11, 2025 approved Nuvation's Ibtrozi for ROS1-positive non-small cell lung cancer. Track the deals that are happening here. Sanofi’s $9.1
2025 [link] The coronavirus disease 2019 (COVID-19) pandemic crisis has been mitigated by worldwide efforts to develop vaccines and therapeutic drugs. However, there remains concern regarding public health and an unmet need for therapeutic options.
Lets take a look at these letters: Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health. Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. that it is effective on Day 1) and insinuating misleading comparative claims.
By Jacob Bell • July 1, 2025 Kendall Davis/BioPharma Dive Tracker 10 clinical trials to watch the rest of 2025 Expected readouts in obesity, lung cancer and AATD headline a series of study results that could give the biotechnology sector a boost. By BioPharma Dive staff • Updated June 30, 2025 Keep up with the story. inhibitors.
Published June 26, 2025 Gwendolyn Wu Senior reporter post share post print email license B cells, like those pictured above, malfunction in autoimmune disease. Vor Biopharma licensed a drug in June 2025 that targets proteins essential to B cell survival. You can unsubscribe at anytime. Sign up A valid email address is required.
Published July 16, 2025 • Updated 2 hours ago Ben Fidler Senior Editor post share post print email license Sarepta Therapeutics announced a workforce reduction on July 16, 2025. Some Wall Street analysts predicted sales might top $2 billion in 2025. By Ben Fidler and Gwendolyn Wu • Updated June 19, 2025 Keep up with the story.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Dive Brief Moderna COVID vaccine gets full approval for children The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., Kennedy Jr.
Published July 18, 2025 Delilah Alvarado Staff Reporter post share post print email license Food and Drug Administration Commissioner Martin Makary speaks on stage during The Semafor 2025 World Economy Summit on April 24, 2025 in Washington, DC. By Jacob Bell • July 1, 2025 Keep up with the story. inhibitors. inhibitors.
Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat. By Jonathan Gardner • Updated April 9, 2025 Keep up with the story.
Published July 18, 2025 • Updated 3 hours ago Ned Pagliarulo Lead Editor post share post print email license The U.S. By BioPharma Dive staff • Updated June 30, 2025 Yujin Kim / MedTech Dive, original photo courtesy of U.S. By BioPharma Dive staff • Updated July 2, 2025 Keep up with the story.
WEDNESDAY, July 23, 2025 — Cancer patients can be very vulnerable to a severe COVID infection, but COVID-19 vaccine boosters can be lifesavers for them, a new study says. COVID boosters reduced cancer patients’ hospitalizations and ICU.
FRIDAY, July 25, 2025 — It's official: The controversial preservative thimerosal will be stripped from all flu vaccines distributed in the United States. According to the CDC, influenza (flu) vaccines are currently available in both.
The world continues to feel the ripple effects of the COVID-19 pandemic, even into 2025. While vaccines, therapeutics, and preventive measures have significantly reduced the global burden of the disease, […] The post COVID-19 in 2025: Are Decentralized Clinical Trials the New Standard?
MONDAY, May 19, 2025 The U.S. Food and Drug Administration (FDA) has granted full approval to Novavaxs COVID-19 vaccine, but only for certain people.The vaccine is now approved for adults ages 65 and older, or for people ages 12 to 64 who have at.
FRIDAY, July 11, 2025 — Moderna’s COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children with medical conditions that put them at higher risk of severe illness.The move makes Moderna’s vacci.
Published July 9, 2025 By Kristin Jensen post share post print email license Merck & Co. 4, 2024 Kendall Davis/BioPharma Dive Tracker 10 clinical trials to watch the rest of 2025 Expected readouts in obesity, lung cancer and AATD headline a series of study results that could give the biotechnology sector a boost.
MONDAY, July 28, 2025 — More than 2.5 million deaths were prevented worldwide by the cutting-edge vaccines developed for COVID-19, mainly among seniors, a new analysis says. Essentially, one death was averted for every 5,400 doses.
FRIDAY, June 27, 2025 — The U.S. Food and Drug Administration (FDA) has added new warnings to the Pfizer and Moderna COVID-19 vaccines about a rare heart condition that mostly affects young men. The update expands earlier warnings about.
Hamburg, former commissioner of the FDA, is now co-chair of a new initiative, the Vaccine Integrity Project, which is organized by the University of Minnesota’s Center for Infectious Disease Research and Policy. & In addition, David Baltimore and Peggy Hamburg will be departing the Board.
Published June 26, 2025 Ned Pagliarulo Lead Editor post share post print email license An Incyte researcher works in a laboratory. On June 26, 2025, the company announced the replacement of longtime CEO Hervé Hoppenot with Bill Meury. says US won’t donate to global vaccine effort View all Events 07 JUL Webinar | 10 a.m.
Redefining vaccine trial recruitment Clinical trials are vital for developing safe and effective vaccines, but their success relies on overcoming recruitment challenges and ensuring diverse study cohorts. Discover innovative, data-driven recruitment strategies to ensure diverse, efficient, and high-quality vaccine trials.
Published June 27, 2025 Ned Pagliarulo Lead Editor post share post print email license Bristol Myers Squibb sells two CAR-T cell therapies for cancer. On June 26, 2025, the Food and Drug Administration eased some of the medicines' reporting requirements. Hiroyuki Okuzawa is working to keep it that way. Can they keep it?
WHO Maintains Global Health Emergency Status for Mpox Amid 2024 Surge, Issues Strengthened Recommendations In response to the continuing resurgence of mpox across several regions in 2024, the World Health Organization (WHO) convened the fourth meeting of the International Health Regulations (2005) Emergency Committee on 5 June 2025.
“Timely access to HIV and syphilis testing and treatment, along with mpox vaccines and antivirals, is essential to save lives and prevent further transmission.” Initially launched across five mpox treatment centers, the integrated testing approach now spans 11 health zones.
FRIDAY, June 27, 2025 — A U.S. vaccine advisory panel voted Thursday to stop recommending flu shots that contain thimerosal, a move that experts say may reduce access to vaccines without making them any safer. The vote came from a newly.
TUESDAY, July 1, 2025 — Moderna’s new flu vaccine, based on the same mRNA technology used in its COVID-19 shot, showed promising results in a major trial, the company announced Monday. The vaccine, called mRNA-1010, was tested in a.
Importantly, a study assessing the effects of this medication on dogs’ ability to respond to vaccines demonstrated that NUMELVI had no measurable impact on their vaccine responses — a strong indicator that it maintains the functionality of the adaptive immune system while addressing disease symptoms.
After all, it likely doesn’t really matter in 2025 whether Hippocrates made people drink 41 cups of willow bark tea a day, or if people write historical fiction where characters rush off to find willow bark to quell a fever. But it does matter whether people believe, for instance, that vaccination is the best way to prevent measles.
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