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FDA Expands Sarepta's (SRPT) DMD Gene Therapy Label
Zacks· 2 days agoFree Report) rose nearly 34% in after-market trading on Thursday after it announced that the FDA approved the expanded use of its Duchenne muscular dystrophy (DMD) gene therapy ...
FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'
FierceBiotech· 6 days agoThe FDA has slammed the brakes on a trial of MediLink Therapeutics’ BioNTech-partnered antibody-drug...
FDA approves Biotest’s plasma-derived treatment for immunodeficiencies
BioPharma-Reporter· 3 days agoYimmugo, an intravenous immunoglobulin therapeutic, is the first therapy developed by Biotest to be...
FDA OKs first menthol e-cigarettes, citing potential to help adult smokers
WSLS Newschannel 10 Roanoke· 2 days agoThe Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, the government’s strongest indication yet that vaping flavors can reduce ...
FDA Plans to Ease Requirements for Biosimilars' Interchangeable Status
MedPage Today· 3 days agoThe FDA on Thursday announced that biosimilars seeking an interchangeable status would no longer require studies showing that switching between a biosimilar and its branded ...
FDA says Dollar Tree left lead-tainted applesauce pouches on store shelves for weeks after recall
WIFR Rockford· 5 days agoThe FDA sent a warning letter to Dollar Tree this month and placed Negasmart, the Ecuadorian...
FDA OKs first menthol e-cigarettes, citing potential to help adult smokers
Associated Press via AOL· 2 days agoThe Food and Drug Administration on Friday authorized menthol-flavored electronic cigarettes for adult smokers, the government’s strongest indication yet that vaping flavors can reduce the harms ...
FDA OKs first menthol e-cigarettes, citing potential to help adult smokers
WBAL-TV Baltimore· 2 days agoThe FDA said it authorized four menthol e-cigarettes from NJOY, the vaping brand recently acquired...
FDA Expands Orphan Drug Designation for SurVaxM, I | Newswise
Newswise· 2 days agoBUFFALO, N.Y. — The U.S. Food and Drug Administration (FDA) has expanded orphan drug designation for SurVaxM, a brain cancer immunotherapy born in the labs of Roswell Park ...
Pharma Stock Roundup: FDA Nod to MRK's New Jab & Expanded Use of ABBV & AZN Drugs
Zacks via Yahoo Finance· 2 days agoFDA approves Merck's (MRK) 21-valent pneumococcal conjugate vaccine, Capvaxive and the expanded use...