Moderna

The FDA approved the nation's first mRNA flu vaccine on Wednesday. The vaccine was manufactured by drugmaker Moderna.

The U.S. Food and Drug Administration approved Moderna’s mRNA flu vaccine, mFLUSIVA, for adults 50 years and older, issuing an accelerated approval for those 65 and older. The vaccine was found to be about 27% more effective than standard flu shots in a study involving over 40,000 adults. Officials anticipate the shot will be ready in time for the 2026-27 respiratory virus season.

The Food and Drug Administration (FDA) approved the nation’s first mRNA flu vaccine, which was manufactured by Moderna. The agency granted approval for two distinct age groups: individuals between 50 and 64, and those aged 65 years and older. Following the approval, Moderna announced plans to conduct a postmarket clinical trial.

The FDA approved Moderna’s mRNA flu vaccine. The agency had initially refused to review the application but subsequently reversed course after a public outcry.

Moderna has launched an early trial of an Ebola mRNA vaccine. The article also mentions earnings reports from Amgen, Gilead Sciences, United Therapeutics, Novo, and Lilly.

Moderna is testing its first mRNA Ebola vaccine with funding from CEPI as the Ebola outbreak in the Congo surpasses 3,700 confirmed cases and 1,600 deaths.

Moderna has started human trials for an experimental Ebola vaccine in Canada. The initiative is supported by the Coalition for Epidemic Preparedness Innovations, which has pledged up to $50 million.

The article discusses the FDA's upcoming decision on Moderna's mRNA flu shot, a renewed debate over 340B rebates, and legal challenges regarding Lilly's insulin pricing. It highlights key developments in the biotech and pharmaceutical sectors.

The FDA is considering Moderna's mRNA-based flu shot, which could be the first of its kind. The decision may impact the biotech industry. The technology has been questioned by RFK Jr.

The FDA is set to decide on Moderna's mRNA-based flu shot, potentially the first of its kind, which could significantly impact the biotech industry. The decision involves technology that RFK Jr. has questioned.

Moderna exceeded Wall Street's loss estimates, but its norovirus vaccine trial failed to meet a key objective, leading to a decline in its stock price.

Investors are cautiously optimistic about potential IPOs from Anthropic and OpenAI following SpaceX's $2 trillion debut. Financial advisors like Jeff Barnett highlight risks of first-day IPO purchases, noting historical underperformance of many initial winners. The article compares SpaceX's IPO to past biotech successes like Moderna, emphasizing long-term investment strategies.

Talawar is leveraging a bispecific approach to potentially disrupt the eczema market. The article also highlights a SPAC for a bispecific maker, Moderna's advancing mRNA ambitions, and Clive Meanwell's perspective on AI's role in biotech drug design.

Kenneth Chien, a co-founder of Moderna, received an Hermes belt from CEO Stéphane Bancel after securing a partnership with AstraZeneca. This deal accelerated Moderna's growth, leading to significant funding and the development of mRNA-based Covid vaccines, though the planned drugs for cancer and cardiovascular disease did not materialize.

FDA advisors unanimously voted to approve Moderna's mRNA vaccine following internal agency drama. The approval represents a key regulatory decision for the company's vaccine development.

An FDA panel recommended an mRNA flu vaccine for older adults. The final decision on Moderna’s flu shot is unclear due to the FDA lacking a permanent vaccine chief and commissioner.

A key FDA committee unanimously voted to recommend Moderna's new mRNA influenza vaccine for adults 50 and over. The recommendation marks the committee's first vaccine approval since 2023.

A key FDA committee unanimously recommended Moderna's new mRNA influenza vaccine for adults aged 50 and over. All nine committee members voted in favor of the recommendation.

An FDA advisory panel unanimously recommended Moderna’s mRNA-based flu vaccine, mFlusiva, for approval in adults aged 50-64 and 65+. The panel voted 9-0 that the benefits outweigh the risks for the vaccine.

An FDA panel has recommended Moderna’s mRNA flu shot for older adults. The recommendation highlights the potential of mRNA vaccines to be developed and updated quickly to match circulating flu strains later in the year.

An FDA advisory panel unanimously endorsed Moderna's mRNA flu vaccine, concluding its benefits outweigh risks for adults aged 50-64 and those 65+. The FDA may license it via traditional and accelerated pathways, with existing vaccines having used similar routes. Wellington Sun, a former FDA employee who later worked for Moderna, commented on accelerated pathways during the meeting.

An FDA panel recommended approval of Moderna's first mRNA-based flu vaccine, mFlusiva, for adults aged 50 and older, citing its benefits outweighing risks. The vaccine, developed using technology similar to COVID-19 vaccines, showed a 27% reduction in flu cases compared to traditional vaccines in clinical trials and is under final FDA review for potential approval by August.

Moderna is seeking FDA approval for its new flu vaccine, mFlusiva, targeting individuals 50 and older. The FDA advisory committee meeting is a critical step toward a final decision before the winter flu season.

Johnson & Johnson has decided not to enter the obesity market, focusing instead on cancer research and acquiring Halda Therapeutics for prostate cancer therapy. The FDA approved GSK's antibiotic Utebzi for treating drug-resistant infections, and the article mentions an FDA review of Moderna's flu shot.

Massachusetts was ranked the best economy in the US by a WalletHub study, driven by its top innovation potential and high-tech industries. The state's strong economic activity, high-tech job share, and leading research institutions like Harvard and MIT contribute to its success.

The FDA is considering Moderna's first mRNA-based flu vaccine, mFlusiva, for people 50 and older. A study showed it reduced flu cases by 27% compared to a standard vaccine, but data on frail older adults and those with weak immune systems is lacking. A prior FDA official disputed the vaccine's comparison to a high-dose brand, but the application was later accepted.

The FDA advisory panel is evaluating Moderna's first mRNA-based flu vaccine, mFlusiva, for approval in adults 50 and older. The vaccine, which showed a 27% reduction in flu cases compared to a standard-dose vaccine in a 40,000-person study, faces scrutiny over its study design but has received a favorable FDA review with no safety concerns noted.

The FDA is considering Moderna's first mRNA-based flu vaccine, mFlusiva, for adults 50 and older. A study showed it reduced flu cases by 27% compared to a standard vaccine, but lacks data on very frail older adults. The decision follows a dispute with a former FDA official who questioned the study's design.

FDA reviewers have not raised serious efficacy or safety concerns about Moderna's mRNA flu vaccine candidate ahead of an advisory committee meeting. The vaccine could become the first mRNA-based flu shot approved by the FDA.

Moderna and other companies are developing an mRNA vaccine to combat the Bundibugyo virus, which is driving the current Ebola outbreak. The effort focuses on addressing the rare virus causing the ongoing epidemic.

Scientists are developing four Ebola vaccines to address the Bundibugyo strain outbreak in eastern DR Congo, with two candidates potentially entering clinical trials by summer. The outbreak, which has reported over 500 cases, faces challenges including delayed detection and reduced health resources due to aid cuts. The Africa CDC has urged strengthened border screening measures to prevent cross-border transmission.

An EU court adviser recommended rejecting the European Commission's appeals to keep vaccine contract details secret, supporting transparency campaigners' push for public access to negotiations and conflict-of-interest information. The decision upholds a lower court ruling that found the Commission failed to justify withholding key documents.

An AI-powered cybersecurity platform by XBOW discovered a vulnerability leading to a full takedown of Moderna's development environment, highlighting the growing shift in the industry as AI models outpace human teams in identifying vulnerabilities. Experts warn that the volume of AI-detected issues exceeds remediation capabilities, with aging infrastructure compounding the challenge.

Maine Senate candidate Graham Platner, known for criticizing corporations like Big Pharma, accepted over $30,000 in donations from lobbyists and executives representing those industries between August 2025 and March. Despite pledging to reject contributions over $200 from healthcare industry affiliates, Platner received $1,000 each from lobbyists working for AbbVie, Novartis, and Moderna, though one donation was later returned.

Graham Platner, a Maine Senate candidate, faces scrutiny for accepting over $30,000 from lobbyists and executives at major corporations while campaigning against big tech, pharmaceuticals, banks, and defense contractors. Despite pledging to reject contributions over $200 from healthcare industry lobbyists, Platner received $1,000 donations from lobbyists representing AbbVie, Novartis, and Moderna prior to making the pledge.

A new personalized mRNA cancer therapy, intismeran autogene, combined with KEYTRUDA, reduced melanoma recurrence or death risk by 49% over five years in a phase 2b study. The treatment, developed by Merck and Moderna, showed sustained benefits and a manageable safety profile in high-risk melanoma patients. It is now in phase 3 trials.

CEPI has committed $50 million to Moderna for preclinical development and Phase 1 testing of an mRNA-based vaccine against Bundibugyo ebolavirus (BDBV). The funding aims to accelerate efforts to address an outbreak in the Democratic Republic of the Congo, leveraging Moderna's mRNA platform used during the COVID-19 pandemic.

Congo reports 282 confirmed Ebola cases in an outbreak linked to the Bundibugyo virus, with 42 deaths in Congo and one in Uganda. Recovery stories of medical workers highlight progress despite challenges in containment, while a $62 million commitment accelerates vaccine development.

The Coalition for Epidemic Preparedness Innovations (CEPI) will invest $50 million to develop and test Moderna's vaccine against the Bundibugyo strain of Ebola. The funding may also support manufacturing and later-stage trials if early data are positive.

A personalized mRNA vaccine developed by Moderna and Merck shows promise in reducing the recurrence of melanoma, the deadliest form of skin cancer, according to a five-year follow-up of a Phase 2b study.