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Regulatory Affairs

FDA FDA Approval FDA Approvals Drug Approval FDA Approval Process Drug Approval Process European Medicines Agency FDA Regulations Drug Approval Processes Health Canada Drug Safety Clinical Trials FDA Authorization Vaccine Approval Biologics License Application Health Regulators WHO Prequalification

EU Drug Agency Recommends Approval of First Alzheimer’s Treatment Targeting Disease Progression

FDA Declares Semaglutide Shortage Over, Impacting Compounded Drug Market

Biogen Reports Mixed Q4 Results and Lowers 2025 Outlook

Experimental Vaccine Keeps Kidney Cancer Patients Cancer-Free for Three Years

Moderna Cuts 2025 Revenue Forecast by $1 Billion, Shares Drop Over 20%

Medicare to Cover Eli Lilly’s Zepbound for Sleep Apnea Treatment

Pfizer Ends Hemophilia Gene Therapy Partnership With Sangamo, Sending Stock Plummeting

Systane Eye Drops Recalled Over Potential Fungal Contamination

Systane Eye Drops Recalled Nationwide Over Fungal Contamination Risk

Ozempic Linked to Rare Eye Condition, EU to Investigate

Cassava Sciences Halts Alzheimer’s Drug Trials Following Phase 3 Failure

EMA Approves Lecanemab for Early-Stage Alzheimer’s Treatment in EU

FDA Proposes Removal of Ineffective Oral Phenylephrine from Cold Medicines

Ozempic and Wegovy Now Available After Prolonged Shortages

Novo Nordisk's Oral Semaglutide Shows 14% Reduction in Heart Risks

FDA Halts Novavax's COVID-Flu Combo Vaccine Trial Over Safety Concerns

RSV Vaccine Sales Decline Sharply in U.S. Amid Narrowed Eligibility

Boehringer Ingelheim's Survodutide Wins FDA Breakthrough Status for MASH Treatment

Thermo Fisher's Greenville Plant Cited for FDA Rule Breaches

Pfizer Withdraws Sickle Cell Drug Oxbryta Over Safety Concerns

Health Canada Approves Pfizer's Updated COVID-19 Vaccine

FDA Approves First At-Home Nasal Spray Flu Vaccine

FDA Approves First Treatment for Niemann-Pick Disease Type C

Health Canada Approves Moderna's Updated COVID-19 Vaccine

Pfizer's New Drug Shows Promise in Combatting Cancer-Related Weight Loss

New Biannual HIV Injection Reduces Infection Risk by 96%

Lenacapavir Injection Shows 96% Efficacy in Preventing HIV

Study Finds CAR-T Therapy Does Not Increase Risk of Secondary Cancer

New Studies Confirm Safety of Semaglutide for Mental Health

FDA Authorizes New Novavax Vaccine Targeting Omicron Variant

New Study Links Ozempic to Increased Risk of Suicidal Thoughts

FDA Approves Neffy, the First Needle-Free Epinephrine Nasal Spray for Anaphylaxis

FDA Approves Neffy: First Needle-Free Epinephrine Nasal Spray for Allergic Reactions

New Alzheimer's Drugs Face Scrutiny Over Efficacy and Safety

Eli Lilly's Zepbound Shows Promise in Reducing Heart Failure Risks

Weight-Loss Drugs Reshape Health and Consumer Markets

FDA Issues Warning on Overdoses from Compounded Semaglutide Injections

FDA Approves Blood Test for Colorectal Cancer Screening

EU Regulator Denies Approval for Alzheimer's Drug Lecanemab

UK Approves Wegovy for Reducing Heart Risks in Overweight Patients