Chester County News and Community Website
BALA CYNWYD, PA — Larimar Therapeutics, Inc. (Nasdaq: LRMR) plans to begin a rolling FDA biologics license application submission next month for its experimental Friedreich’s ataxia treatment nomlabofusp as the …
Larimar Targets FDA Filing for Friedreich’s Ataxia Drug Read More
PHILADELPHIA, PA — Lannett Company announced that the U.S. Food and Drug Administration approved LANGLARA, an interchangeable biosimilar to Lantus insulin, expanding the number of lower-cost insulin treatment options available …
FDA Approves Interchangeable Lantus Biosimilar for Diabetes Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration recently launched new safety reviews of two widely used food additives while finalizing a broader framework for reassessing chemicals already approved …
FDA Expands Review of Food Additives Under Safety Program Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration is seeking public input on expanding the use of existing approved medicines for new diseases and patient populations, part of a …
FDA Explores Wider Use of Existing Drugs for Chronic Disease Read More
NEWTOWN SQUARE, PA — ArriVent BioPharma (Nasdaq: AVBP) received U.S. Food and Drug Administration clearance to begin human testing of an experimental antibody-drug conjugate designed to improve targeting of ovarian …
ArriVent Pushes Dual-Target Ovarian Cancer Drug Into Trials Read More
WILMINGTON, DE — NRx Pharmaceuticals (Nasdaq: NRXP) received U.S. Food and Drug Administration clearance to begin a late-stage clinical trial evaluating whether its investigational NRX-101 therapy can improve outcomes for …
NRx Advances Depression Drug Study Targeting Military Use Read More
RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) received U.S. Food and Drug Administration acceptance for its application seeking approval of lorundrostat for uncontrolled or resistant hypertension, moving the company …
Mineralys Advances Hypertension Drug Toward FDA Decision Read More
WILMINGTON, DE — Incyte (Nasdaq: INCY) recently received U.S. Food and Drug Administration approval for Jakafi XR, a once-daily extended-release version of ruxolitinib, giving patients with several chronic blood disorders …
FDA Approves Once-Daily Jakafi XR for Blood Disorders Read More
WILMINGTON, DE — An advisory committee to the U.S. Food and Drug Administration voted 7-1, with one abstention, that AstraZeneca’s TRUQAP combination therapy demonstrated a favorable benefit-risk profile for patients …
FDA Panel Backs AstraZeneca Prostate Cancer Drug Combo Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved Bizengri for adults with advanced NRG1 fusion-positive cholangiocarcinoma, marking the first approved treatment for the rare bile duct cancer …
FDA Approves Bizengri for Rare Bile Duct Cancer Read More