Fda Approves

• The FDA has approved a new engineered viral immunotherapy designed specifically for patients suffering from treatment-resistant advanced melanoma. • This approval provides a critical new therapeutic option for cancer patients who have failed to respond to existing standard-of-care treatments. • The authorization is granted under conditions where continued market availability may be contingent upon the verification of clinical benefits.

• The FDA has authorized Moderna’s mFlusiva, marking the first mRNA-based flu vaccine approved for use in older adults. • Separately, U.S. health officials are reviewing the nation's measles elimination status following 38 new outbreaks in 2026. • In a legal ruling, a judge designated Meta’s platforms as a "public nuisance," ordering the company to fund mental health remediation efforts.

• The FDA has approved mFlusiva, marking the first time an mRNA-based vaccine has been authorized for the prevention of influenza. • Unlike traditional flu vaccines, mRNA technology allows manufacturers to produce shots more rapidly, reducing the likelihood of a mismatch between the vaccine and circulating strains. • Medical experts, including Dr. Paul Pottinger of UW Medical Center, describe the approval as a significant advancement in public health.

• The FDA has approved Replimune’s treatment for advanced melanoma, marking a significant victory for the company and patient advocates. • The drug's approval follows a tumultuous process in which it was previously rejected by the agency twice before clearing an advisory committee last week. • This decision provides a critical new therapeutic option for patients suffering from advanced stages of skin cancer.

• The FDA has approved Moderna's new mRNA-based flu vaccine, named mFlusiva, which is specifically intended for adults aged 50 and older. • This approval marks a shift toward using mRNA technology for seasonal influenza, moving away from traditional egg-based vaccine production methods. • The development is significant as it aims to provide more precise and potentially more effective protection against evolving flu strains.

• The FDA approved mFlusiva, the first mRNA-based flu vaccine developed by Moderna, on Wednesday. • The vaccine is approved for adults aged 50 to 65 and those 65 and older, with late-stage trials showing it is approximately 27% more effective than standard flu shots. • This approval is significant as it applies the same messenger RNA platform used in Pfizer and Moderna's COVID-19 vaccines to seasonal influenza.

• The U.S. FDA has approved Moderna's first mRNA-based influenza vaccine specifically for adults aged 50 and older. • This decision follows a reversal of a previous refusal and leverages mRNA technology that was rapidly accelerated and proven safe during the COVID-19 pandemic. • The approval is significant as it expands the use of mRNA technology to combat seasonal diseases, while Health Canada is currently considering its own approval of the shot.

• The FDA has approved mFlusiva, the first mRNA-based influenza vaccine developed by Moderna, specifically targeting adults aged 50 and older. • The regulatory strategy includes full approval for adults aged 50 to 64 and accelerated approval for those 65 and older, pending a postmarketing study using a high-dose comparator. • This approval follows a unanimous recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee in June 2026.

• The FDA has approved Moderna's mFLUSIVA, the first seasonal influenza vaccine utilizing mRNA technology to receive official authorization. • The vaccine is specifically approved for use in adults aged 50 and older, marking a significant milestone for the drugmaker's mRNA platform. • This approval is critical as it demonstrates the potential for mRNA technology to address broader public health challenges beyond COVID-19.

• The FDA has approved the first mRNA-based flu vaccine, developed by Moderna, specifically for adults aged 50 and older. • Former FDA vaccine regulator Jesse Goodman noted the shot's documented superiority in effectiveness over standard doses for the 50-64 age group, particularly those with underlying health conditions. • The new vaccine serves as a potent alternative for seniors 65 and over and will be covered by Medicare, according to KFF health policy expert Jennifer Kates.

• The FDA has approved Moderna’s mFlusiva, marking the first time a licensed influenza vaccine has been developed using messenger RNA (mRNA) technology. • This approval represents a significant milestone for mRNA, a platform that gained global prominence during the COVID-19 pandemic but has faced scrutiny from vaccine skeptics. • The shift to mRNA for flu shots is critical because the technology allows for faster production and potentially better matching to evolving seasonal virus strains.

• The FDA has approved Lipfendra, a new cholesterol-lowering pill developed by Merck. • Unlike traditional statins, Lipfendra is a PCSK9 inhibitor, utilizing a different mechanism to reduce cholesterol levels in patients. • This approval provides a new oral therapeutic option for managing high cholesterol, offering an alternative for those who may not respond well to statins.

• The FDA has approved the oral antiviral ensitrelvir (Xocova), developed by Shionogi & Co, Ltd, for post-exposure prophylaxis (PEP) of COVID-19. • The treatment is authorized for use in adults and adolescents aged 12 years and older to prevent symptomatic SARS-CoV-2 infection. • Approval was based on the SCORPIO-PEP phase 3 trial, which demonstrated the drug's safety and efficacy in household contacts of symptomatic patients.

• The U.S. FDA has approved ensitrelvir (Xocova), an oral antiviral developed by Shionogi, for the post-exposure prevention of COVID-19. • The medication is authorized for use in individuals aged 12 years and older who have been exposed to the SARS-CoV-2 virus. • This approval is significant as Xocova becomes the first and only oral medication specifically authorized to reduce the risk of infection after a known exposure.

• The FDA has approved Shionogi’s Xocova (ensitrelvir) as the first oral therapy designed to prevent Covid-19 after a person has been exposed to the virus. • The approval follows the Scorpio-Pep trial involving 2,387 participants aged 12 and older who were asymptomatic but had been exposed to a symptomatic household member. • The drug works by inhibiting viral replication, offering a critical new preventative tool for those who initiate treatment within 72 hours of their contact's symptom onset.

• The FDA has approved the oral medication ensitrelvir for use as post-exposure prophylaxis (PEP) to prevent the onset of COVID-19 symptoms. • Approval follows phase 3 clinical trial data conducted between February 10 and July 10, 2022, across 92 sites in Japan, Vietnam, and South Korea, demonstrating efficacy against Omicron variants. • This development is significant as it provides a preventative option for individuals exposed to the virus in high-risk environments, including nursing homes, acute care facilities, and during travel.

• The FDA has approved ensitrelvir, an oral antiviral medication specifically designed to prevent COVID-19 after a person has been exposed to the virus. • Approval follows the phase III SCORPIO-PEP trial, which demonstrated that the drug reduced the risk of developing COVID-19 by more than half for individuals who were household contacts of an infected person. • This marks a significant shift in prevention strategy, though the medication is currently not approved for treating active COVID-19 infections within the U.S.

• The FDA granted approval on April 7, 2026, to Moderna's mRESVIA vaccine, an mRNA-based shot targeting respiratory syncytial virus (RSV) for adults aged 60 and older. • Clinical trials showed 83.7% efficacy against RSV lower respiratory tract disease in the first season, with data from over 37,000 participants across 22 countries including US sites. • This marks the second mRNA RSV vaccine approved after GSK's Arexvy, aiming to reduce 140,000-160,000 annual US hospitalizations among seniors; CDC review expected soon.

• The FDA granted accelerated approval to a novel immunotherapy combination for metastatic pancreatic cancer on March 21, 2026, based on Phase 2 trial data showing a 35% response rate. • The drug combination demonstrated a median overall survival of 14.2 months compared to 11.8 months with standard chemotherapy in the clinical trial of 280 patients. • Pancreatic cancer remains one of the deadliest cancers with a five-year survival rate below 12%, making this approval potentially significant for the estimated 64,000 Americans diagnosed annually.

• The FDA approved the first RSV vaccine for infants via maternal immunization on March 18, 2026, allowing pregnant women to receive vaccination in the third trimester to confer passive immunity to newborns. • The approval is based on a Phase 3 trial showing 82% efficacy in preventing severe RSV disease in infants under six months, with passive immunity lasting approximately three months post-birth. • RSV causes approximately 100,000 hospitalizations and 300-400 deaths annually among US infants, making this vaccine potentially transformative for preventing severe respiratory illness in the most vulnerable population.