Chester County News and Community Website
WILMINGTON, DE — The U.S. Food and Drug Administration has accepted and granted Priority Review to a supplemental application for ENHERTU, a breast cancer treatment developed by AstraZeneca and Daiichi …
FDA Grants Priority Review to ENHERTU for Early Breast Cancer Use Read More
WASHINGTON, D.C. — The U.S. Department of Energy has approved an immediate increase in natural gas exports from a major liquefied natural gas terminal in Louisiana, allowing the facility to …
LNG Export Expansion Approved for Louisiana Energy Terminal Read More
WASHINGTON, D.C. — The U.S. Department of Veterans Affairs and the Department of Justice have signed an agreement that will allow VA attorneys to take a more active role in …
VA, DOJ Partnership Expands Legal Support for Vulnerable Veterans Read More
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WASHINGTON, D.C. — The U.S. Food and Drug Administration announced new draft guidance aimed at reducing the cost and complexity of developing biosimilar medicines, a move the agency says could …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 U.S. Department of the Interior announced a series of policy proposals and agreements this week affecting offshore energy regulation, Alaska Native probate services, and wildlife management …
Interior Proposes Energy, Wildlife, Alaska Probate Policy Changes 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