FDA
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Synthetic Dye Ban Puts Philadelphia’s Classic Treats at Risk
With the Department of Health and Human Services, led by Robert F. Kennedy Jr., moving to phase out eight petroleum-based…
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Plymouth Meeting’s Harmony Biosciences Pivots After FDA Rejects Wakix for Sleep Disorder
Plymouth Meeting’s Harmony Biosciences’ stock fell 10% on Wednesday after the FDA rejected the expansion of its insomnia drug, Wakix,…
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Plymouth Meeting’s Harmony Biosciences Eyes $3B in Sales with New Treatments on the Way
Since launching in 2017, Plymouth Meeting’s Harmony Biosciences has grown from a small drug developer into a billion-dollar company, writes…
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Doylestown Surgeons Pioneer Dissolvable Stents for Clearing Blocked Leg Arteries
Vascular surgeons at Doylestown Hospital have pioneered a dissolvable stent that holds clogged arteries open long enough to heal, according…
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Plymouth Meeting’s Zelira Therapeutics Takes Unconventional Approach Cannabis
Zelira Therapeutics, a biopharmaceutical company with operations in Plymouth Meeting and Australia, is preparing to launch clinical trials for its…
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Conshohocken’s Madrigal Pharmaceuticals Reports Sales Through the Roof
Conshohocken’s Madrigal Pharmaceuticals, saw third-quarter sales soar for its NASH treatment, Rezdiffra, writes John George for the Philadelphia Business Journal.…
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Bimbo Bakeries in Horsham Gets FDA Warning Over Mislabeling
Bimbo Bakeries USA, based in Horsham, has received a warning letter from the U.S. Food and Drug Administration indicating it…
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Harmony Biosciences in Plymouth Meeting OK’d for Sleep Disorder Drug Use
Plymouth Meeting-based Harmony Biosciences received a green light from the Food and Drug Administration to widen the use of Wakix,…
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Bala Cynwyd-Based Larimar Therapeutics Chosen for FDA’s START Pilot Program
The Food and Drug Administration has selected Bala Cynwyd-based Larimar Therapeutics’ lead drug candidate for its new program inspired by…
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Delaware County Health Department Takes Exception to John Oliver Mention
The Delaware County Health Department got a mention on John Oliver’s program “Last Week Tonight” Sunday night but officials weren’t…
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All Eyes Are on Madrigal Pharmaceuticals as FDA’s Decision Draws Closer
Later this week, the U.S. Food and Drug Administration is expected to make a decision on Madrigal Pharmaceuticals’ experimental NASH…
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Inovio Getting Closer to Seeking FDA Approval for Its First DNA Medicine
Plymouth Meeting’s Inovio Pharmaceuticals is getting closer to seeking U.S. Food & Drug Administration approval for its first DNA medicine,…
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Active Protective Technologies’ Tango Belt Reduces Traumatic Fall Risk
Fort Washington’s Active Protective Technologies has received FDA breakthrough device designation for its Tango Belt, writes John George for the…
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WSJ: University City-based BioTech Firm Nears Human Trials for Breakthrough Artificial Womb Technology
University City-based Vitara Biomedical is currently working on an artificial womb for premature babies and is getting closer to human…
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Local Meteorologist Who Advocated Against Restrictions, Donates Blood for First Time in Devon
After spending years advocating against the FDA-enacted restrictions that critics believe to be discriminatory against gay and bisexual men, Adam…
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West Chester-Based Verrica Finally Gets Approval for Skin Disease Treatment
A West Chester pharmaceutical company finally achieved federal approval of a new drug candidate that treats a contagious skin disease,…
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Salus University Dean Inducted into the National Optometry Hall of Fame
During his 40 years at the Pennsylvania College of Optometry at Salus University in Elkins Park, Mitchell Scheiman, OD, PhD…
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After Four Long Years, Plymouth Meeting-Based Braeburn Receives FDA Clearance for Opioid Use Disorder Drug
Braeburn, which is based in Plymouth Meeting, has received Food and Drug Administration marketing clearance for its opioid use disorder…
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