Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced new draft guidance aimed at reducing the cost and complexity of developing biosimilar medicines, a move the agency says could …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 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
HARRISBURG, PA — The Pennsylvania Gaming Control Board approved $112,500 in fines against three gaming operators and barred eight individuals from gambling statewide during its public meeting Wednesday.
Pa. Gaming Board Fines Casinos, Bars 8 from Gambling Read More
PHILADELPHIA, PA — Instanosis Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Xylazine Rapid Test (Urine), a diagnostic device designed to detect …
FDA Grants Breakthrough Status to Instanosis Xylazine Test Read More
PLYMOUTH MEETING, PA — Harmony Biosciences (Nasdaq: HRMY) said the U.S. Food and Drug Administration has approved a supplemental new drug application for WAKIX (pitolisant) tablets to treat cataplexy in …
FDA Approves Harmony’s WAKIX for Pediatric Cataplexy Read More