Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration has launched a new centralized system that will allow scientists, regulators, and the public to analyze safety reports for drugs, vaccines, …
FDA Launches Real-Time Safety Database for Drugs and Vaccines Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has approved expanded use of the drug Wellcovorin for patients with a rare genetic neurological disorder, providing the first FDA-approved treatment …
FDA Approves First Treatment for Rare Brain Folate Disorder Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced new draft guidance aimed at reducing the cost and complexity of developing biosimilar medicines, a move the agency says could …
FDA Moves to Cut Costs for Biosimilar Drug Development Read More
LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said the U.S. Food and Drug Administration does not plan to convene an advisory committee for its review of the MOLBREEVI biologics license …
Savara Says FDA Review of MOLBREEVI to Proceed Without Advisory Committee Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for adults …
FDA Approves TECVAYLI and DARZALEX FASPRO Combo for Multiple Myeloma Read More WASHINGTON, D.C. — The Food and Drug Administration this past week took several actions that could affect patients, telehealth providers, drugmakers, and state regulators, issuing warning letters over compounded weight-loss …
FDA Escalates Drug Crackdown While Advancing New Policies Read More SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of IMAAVY (nipocalimab-aahu) …
Johnson & Johnson Submits FDA Application for IMAAVY in wAIHA Read More
BALA CYNWYD, PA — Larimar Therapeutics Inc. (Nasdaq: LRMR) said the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to nomlabofusp for the treatment of adults and children …
FDA Grants Breakthrough Status to Larimar’s Nomlabofusp Read More LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said the U.S. Food and Drug Administration has accepted for review its biologics license application for MOLBREEVI as a treatment for autoimmune pulmonary …
Savara’s MOLBREEVI BLA Receives FDA Priority Review Read More
WILMINGTON, DE — AstraZeneca said the U.S. Food and Drug Administration has approved CALQUENCE (acalabrutinib) in combination with venetoclax as a fixed-duration, all-oral treatment for adults with chronic lymphocytic leukemia …
FDA Approves AstraZeneca’s CALQUENCE Combo for CLL, SLL Read More