Chester County News and Community Website
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
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved a new monthly dosing schedule for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), to …
Johnson & Johnson Receives FDA Approval for Monthly RYBREVANT FASPRO Dosing Read More
WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) said it received guidance from the U.S. Food and Drug Administration that could allow the company to file a New Drug Application …
NRx Reports FDA Guidance on NRX-100 Approval Path Read More
WASHINGTON, D.C. — The U.S. Department of the Interior has expanded West Virginia’s authority to regulate coal mining on federal lands and is opening 2.1 million acres of public land …
Interior Expands State Control Over Coal, Public Lands Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) said it has received “study may proceed” clearance from the U.S. Food and Drug Administration to initiate a Phase 2b dose-optimization trial …
Medicus Pharma Receives FDA Clearance to Begin Phase 2b Teverelix Study Read More