Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a pilot program aimed at dramatically speeding up the back-and-forth communications between drug developers and federal regulators — a …
FDA Tests Rapid-Response System: Will Faster Answers Speed New Drug Development? Read More
WASHINGTON, D.C. — The long-standing FDA warnings on hormone replacement therapy for menopause are being dismantled, as the U.S. Department of Health and Human Services on Monday announced the removal …
HHS Overhauls Menopause Drug Warnings as FDA Unveils Major Women’s Health Shift Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as the first-ever treatment for adults with …
FDA Approves First Treatment for High-Risk Smoldering Multiple Myeloma Read More
PLYMOUTH MEETING, PA — INOVIO (NASDAQ: INO) announced that it has completed the rolling submission of its Biologics License Application (BLA) for INO-3107, a DNA-based immunotherapy candidate for adults with …
INOVIO Submits FDA Application for First DNA Therapy to Treat Rare HPV Disease Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration unleashed a one-two punch this week — first targeting companies peddling dangerous counterfeit Botox online, then accelerating approval for life-saving treatments …
FDA Cracks Down on Fake Botox Sellers, Fast-Tracks Breakthrough Drugs Read More
LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has entered into a $75 million royalty funding agreement with funds managed by RTW Investments, LP, contingent on U.S. Food and Drug Administration …
Savara Secures $75 Million Royalty Deal to Back Potential MOLBREEVI Launch Read More
PHILADELPHIA, PA — GSK plc (LSE/NYSE: GSK) announced that the U.S. Food and Drug Administration has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for adult patients …
GSK Wins FDA Approval for Blenrep Combo in Advanced Multiple Myeloma Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration announced a sweeping set of reforms and enforcement actions last week aimed at lowering prescription drug costs and protecting children from …
FDA Cracks Down on Unapproved Fluoride Drugs, Fast-Tracks Cheaper Biologic Alternatives Read More
WILLOW GROVE, PA — The Institute for Safe Medication Practices (ISMP), a subsidiary of ECRI, has been awarded a contract by the U.S. Food and Drug Administration (FDA) to enhance …
ISMP Awarded FDA Contract to Strengthen Medication Safety Surveillance Read More
WILMINGTON, DE — AstraZeneca and Amgen have received U.S. Food and Drug Administration (FDA) approval for TEZSPIRE® (tezepelumab-ekko) as an add-on maintenance treatment for adults and adolescents aged 12 and …
AstraZeneca and Amgen Secure FDA Approval for TEZSPIRE to Treat Chronic Rhinosinusitis with Nasal Polyps Read More