Novavax’s Nuvaxovid™ 2025-2026 Formula COVID-19 Vaccine Approved in the U.S.
On Aug. 27, 2025, Novavax announced that the U.S. Food and Drug Administration (FDA) has approved the Nuvaxovid™ 2025-2026…
Valneva shares tumble after suspension of U.S. chikungunya vaccine license
On Aug. 25, 2025, shares of French drugmaker Valneva slumped more than 20% after the U.S. Food and…
In a Major Win for Vanda, a Federal Appeals Court Overturns FDA’s Order Denying Approval of Hetlioz for the Treatment of Jet Lag Disorder
On Aug. 18, 2025, Vanda Pharmaceuticals announced that it secured a landmark victory over the U.S. Food and…
Biotechnology | Disease | FDA | Medicine | Therapeutics
Novo Nordisk lowers cost of Ozempic® to $499 per month for self-paying patients
On Aug. 18, 2025, Novo Nordisk announced the launch of a new offer that enables self-paying, eligible, type…
Biotechnology | Disease | FDA | Therapeutics
Wegovy® approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis
On Aug. 15, 2025, Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a…
Precigen Announces FDA Approval of PAPZIMEOS, the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis
On Aug. 15, 2025, Precigen announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zopapogene imadenovec-drba)…
Biotechnology | COVID-19 | FDA | Infectious Disease | NIH | Vaccine
U.S. abandons mRNA vaccine development despite triumphs
On Aug. 8, 2025, the U.S.Department of Health and Human Services (HHS) announced that it was winding down…
Washington Health Officials investigating possible locally acquired case of malaria
On Aug. 6, 2025, the Tacoma-Pierce County Health Department (TPCHD) reported an East Pierce County, Washington woman who…
Biotechnology | Disease | FDA | Therapeutics
FDA approves Alhemo® as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B
On Jul. 31, 2025, Novo Nordisk announced that the US Food and Drug Administration (FDA) approved Alhemo® (concizumab-mtci)…
Biogen Announces $2 Billion Manufacturing Investment in North Carolina’s Research Triangle Park
On Jul. 31, 2025, Biogen announced it intends to invest an additional $2 billion in its existing manufacturing footprint…
Biotechnology | Disease | FDA | Therapeutics
FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys; Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths
On Jul. 18, 2025, the U.S. Food and Drug Administration (FDA) announced it has placed Sarepta Therapeutics investigational…
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease
On Jul. 10, 2025, Moderna announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental…
Biotechnology | Disease | FDA | Neurology | Therapeutics
FDA approves updated label for Lilly’s Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer’s disease
On Jul. 9, 2025, Eli Lilly announced that the U.S. Food and Drug Administration (FDA) has approved a…
Biotechnology | Disease | FDA | Therapeutics
Merck spends $10 billion for Verona, gaining access to its COPD medication
On Jul. 9, 2025, pharmaceutical giant Merck is buying Verona Pharma, a company that focuses on respiratory diseases,…
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NIH will reinstate 900 grants in response to court order
On Jun. 25, 2025, the National Institutes of Health (NIH) moved to reinstate about 900 grants that a…
Biotechnology | Disease | FDA | Medicine | Therapeutics
Dupixent approved in the U.S. as the only targeted medicine to treat patients with bullous pemphigoid
On Jun. 20, 2025, the US Food and Drug Administration (FDA) announced it has approved Dupixent (dupilumab) for…
Biotechnology | CDC | FDA | HIV | Infectious Disease | Medicine | Therapeutics
Yeztugo® (Lenacapavir) Is the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection
On Jun. 18, 2025, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo®…
Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59
On Jun. 12, 2025, Moderna announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345),…
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Kennedy replaces fired U.S. CDC panel members, includes anti-vaccine proponents
On Jun. 12, 2025, U.S. Health Secretary Robert Kennedy Jr. named eight members to serve on a key…
CDC | COVID-19 | FDA | Infectious Disease | Influenza | Measles | NIH | U.S. Congress | Vaccine | Women's Health
US Health Secretary Kennedy guts vaccine advisory committee
On Jun. 9, 2025, Health and Human Services Secretary Robert F. Kennedy Jr. has fired all 17 members…
U.S. FDA Approves Merck’s ENFLONSIA™ (clesrovimab-cfor) for Prevention RSV Lower Respiratory Tract Disease in Infants
On Jun. 9, 2025, Merck announced the U.S. Food and Drug Administration (FDA) has approved ENFLONSIA™ (clesrovimab-cfor) for…
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FDA Launches Agency-Wide AI Tool to Optimize Performance
On Jun. 2, 2025, the U.S. Food and Drug Administration (FDA) announces it has launched Elsa, a generative…
Moderna Received U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE
On May 31, 2025, Moderna announced that the U.S. Food and Drug Administration (FDA) had approved mNEXSPIKE® (mRNA-1283),…
New vaccine policy limits access to COVID shots
On May 20, 2025, The Trump administration said it will limit approval for seasonal COVID-19 shots to seniors…
FDA approves Novavax COVID vaccine with new conditions
On May 17, 2025, The U.S. Food and Drug Administration approved Novavax’s COVID-19 vaccine, but placed additional conditions…
Biology | Diagnostics | Disease | FDA | Medical Device | Neurology | Therapeutics
FDA clears first blood test for Alzheimer’s detection
On May 16, 2025, the U.S. Food and Drug Administration has cleared Fujirebio Diagnostics’ blood test to diagnose…
Disease | FDA | Neurology | Pharmaceutical | Therapeutics
Amneal Receives U.S. FDA Approval for Brekiya® (dihydroergotamine mesylate) injection for Acute Treatment of Migraine
On May 15, 2025, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya®…
Biotechnology | Disease | FDA | Oncology
US FDA approves AbbVie’s drug for a type of lung cancer
On May 14, 2025, The U.S. Food and Drug Administration (FDA) has approved AbbVie’s drug to treat adults…
Biotechnology | Diagnostics | Disease | FDA | Oncology | Women's Health
FDA Approves Teal Health’s Teal Wand™—The First and Only At-Home Self-Collection Device for Cervical Cancer Screening
On May 9, 2025, Teal Health® announced the Food and Drug Administration’s (FDA) approval of the Teal Wand™,…
Biology | Chemical | Environmental | EPA | FDA | Marine Science | Medicine | Pharmaceutical
Antibiotics from human use are contaminating rivers worldwide, study shows
On May 9, 2025, a McGill University led team of researchers announced a study that shows an estimated…