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Government Administration Activities

INOVIO Pharmaceuticals
Regional

FDA Sets 2026 Decision Clock for INOVIO’s Rare Disease Therapy

January 3, 2026January 3, 2026 - by Timothy Alexander

PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) said the U.S. Food and Drug Administration has accepted its Biologics License Application for INO-3107, a potential non-surgical treatment for adults with recurrent …

FDA Sets 2026 Decision Clock for INOVIO’s Rare Disease Therapy Read More

AstraZeneca
Regional

ENHERTU Scores Tenth FDA Fast-Track as Breast Cancer Data Shifts Playbook

December 31, 2025December 30, 2025 - by Timothy Alexander

WILMINGTON, DE — AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) said their jointly developed breast cancer therapy ENHERTU has received Breakthrough Therapy Designation from the U.S. Food and Drug …

ENHERTU Scores Tenth FDA Fast-Track as Breast Cancer Data Shifts Playbook Read More
GSK plc
Regional

FDA Clears GSK’s Twice-Yearly Asthma Drug, Signaling Shift in Biologic Care

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

PHILADELPHIA, PA — GSK plc (LSE/NYSE: GSK) said the U.S. Food and Drug Administration has approved Exdensur, a twice-yearly biologic treatment for patients with severe asthma characterized by an eosinophilic …

FDA Clears GSK’s Twice-Yearly Asthma Drug, Signaling Shift in Biologic Care Read More

AstraZeneca
Regional

FDA Clears ENHERTU Combo as First-Line Breakthrough in HER2 Breast Cancer

December 28, 2025December 26, 2025 - by Timothy Alexander

WILMINGTON, DE — AstraZeneca PLC (NASDAQ: AZN) and Japan’s Daiichi Sankyo said the U.S. Food and Drug Administration has approved ENHERTU in combination with pertuzumab as a first-line treatment for …

FDA Clears ENHERTU Combo as First-Line Breakthrough in HER2 Breast Cancer Read More
Johnson & Johnson
Regional

FDA Clears Five-Minute Lung Cancer Shot, Redefining EGFR Treatment

December 27, 2025December 24, 2025 - by Timothy Alexander

HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) has won U.S. Food and Drug Administration approval for RYBREVANT FASPRO, the first and only subcutaneous therapy for patients with EGFR-mutated non-small …

FDA Clears Five-Minute Lung Cancer Shot, Redefining EGFR Treatment Read More

Palvella Therapeutics
Research

FDA Fast Track Puts Palvella’s Rare Skin Drug on a Faster Regulatory Path

December 23, 2025December 22, 2025 - by Timothy Alexander

WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) said the U.S. Food and Drug Administration has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, a rare …

FDA Fast Track Puts Palvella’s Rare Skin Drug on a Faster Regulatory Path Read More
United States Department of Energy
National / Technology

DOE’s Genesis Mission Taps AI Giants in Bid to Supercharge U.S. Science

December 22, 2025December 21, 2025 - by Maryann Pugh

WASHINGTON, D.C. — The U.S. Department of Energy on Thursday announced new agreements with 24 organizations to help launch the Genesis Mission, a sweeping national initiative that aims to harness …

DOE’s Genesis Mission Taps AI Giants in Bid to Supercharge U.S. Science Read More

Johnson & Johnson
Regional

FDA Clears Breakthrough Precision Combo for Aggressive Prostate Cancer

December 18, 2025December 18, 2025 - by Timothy Alexander

HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has approved an expanded indication for AKEEGA, clearing the first FDA-approved precision medicine combination for …

FDA Clears Breakthrough Precision Combo for Aggressive Prostate Cancer Read More
NRx Pharmaceuticals
Regional

NRx’s Preservative-Free Ketamine Reaches FDA Review as Company Targets 2026 Launch

December 8, 2025December 7, 2025 - by Timothy Alexander

WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) said the U.S. Food and Drug Administration has accepted its Abbreviated New Drug Application for KETAFREE, a preservative-free intravenous ketamine product that …

NRx’s Preservative-Free Ketamine Reaches FDA Review as Company Targets 2026 Launch Read More
AstraZeneca
Regional

AstraZeneca Wins Landmark Approval for IMFINZI Regimen in Early Gastric Cancer

December 8, 2025December 7, 2025 - by Timothy Alexander

WILMINGTON, DE — AstraZeneca secured U.S. approval for its IMFINZI (durvalumab) regimen in combination with FLOT chemotherapy for early-stage and locally advanced gastric and gastroesophageal junction cancers, marking the first …

AstraZeneca Wins Landmark Approval for IMFINZI Regimen in Early Gastric Cancer Read More

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