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Government Administration Activities

GSK plc
Regional

FDA Approves Benlysta Autoinjector for Pediatric Lupus Nephritis Treatment

June 28, 2025June 27, 2025 - by Timothy Alexander

PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) this week approved GSK‘s 200 mg/mL autoinjector of Benlysta (belimumab) for use in children aged five and older who are …

FDA Approves Benlysta Autoinjector for Pediatric Lupus Nephritis Treatment Read More

AstraZeneca
Regional

FDA Grants Accelerated Approval for DATROWAY in Advanced EGFR-Mutated Lung Cancer

June 27, 2025June 26, 2025 - by Timothy Alexander

WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has granted accelerated approval to DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated …

FDA Grants Accelerated Approval for DATROWAY in Advanced EGFR-Mutated Lung Cancer Read More
Food and Drug Administration
National

FDA Introduces Priority Voucher Program to Accelerate Drug Approvals

June 23, 2025June 22, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has unveiled the Commissioner’s National Priority Voucher (CNPV) program, aiming to streamline the drug approval process and address critical health …

FDA Introduces Priority Voucher Program to Accelerate Drug Approvals Read More

Savara
Regional

FDA Requests Additional Data for Savara’s MOLBREEVI Application

June 2, 2025June 1, 2025 - by Timothy Alexander

LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has announced receiving a Refuse-to-File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) of MOLBREEVI, …

FDA Requests Additional Data for Savara’s MOLBREEVI Application Read More
Ocugen
Products and Services

Ocugen Receives Rare Pediatric Disease Designation for OCU410ST

May 29, 2025May 28, 2025 - by Timothy Alexander

MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for its investigational therapy OCU410ST, aimed …

Ocugen Receives Rare Pediatric Disease Designation for OCU410ST Read More

GSK plc
Regional

FDA Approves GSK’s Nucala for COPD Patients with Eosinophilic Phenotype

May 28, 2025May 27, 2025 - by Timothy Alexander

PHILADELPHIA, PA — The U.S. Food and Drug Administration (FDA) has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) with …

FDA Approves GSK’s Nucala for COPD Patients with Eosinophilic Phenotype Read More
Secretary Brooke L. Rollins
National

How USDA’s Bold Moves Are Fighting Wildfires, Saving Farms, and Reshaping SNAP

May 27, 2025May 26, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Department of Agriculture (USDA), led by Secretary Brooke L. Rollins, undertook a series of impactful initiatives last week, ranging from bolstering small family farms to …

How USDA’s Bold Moves Are Fighting Wildfires, Saving Farms, and Reshaping SNAP Read More

FDA
National

Keeping Families Safe: FDA Targets Hidden Dangers in Everyday Food

May 18, 2025May 18, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has unveiled a comprehensive plan to enhance transparency and bolster food safety with a systematic post-market review of food chemicals. …

Keeping Families Safe: FDA Targets Hidden Dangers in Everyday Food Read More
Toddler smiling
National

Protecting Kids’ Health: FDA Moves to Ban Risky Fluoride Products

May 18, 2025May 18, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced its plan to remove concentrated ingestible fluoride prescription products for children from the market, citing health concerns and …

Protecting Kids’ Health: FDA Moves to Ban Risky Fluoride Products Read More
Grilled meat
National

Protect Your Family This Summer: USDA’s Life-Saving Cookout Tips

May 18, 2025May 18, 2025 - by Maryann Pugh

WASHINGTON, D.C. — With summer gatherings and outdoor cookouts in full swing, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has issued crucial food safety guidelines …

Protect Your Family This Summer: USDA’s Life-Saving Cookout Tips Read More

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Trending News

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  • Education Department Shifts Programs in Bid to Cut Red Tape

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