Browsing Tag
US FDA
379 posts
Pfizer gets PAXLOVID FDA approval for COVID-19 in high-risk adults
Pfizer has obtained approval for PAXLOVID, an oral combination therapy of nirmatrelvir tablets and ritonavir tablets, from the…
Hanx Biopharmaceuticals set to begin US clinical trial of HX009 in lymphoma
Hanx Biopharmaceuticals (HanxBio) has obtained approval from the US Food and Drug Administration (FDA) for its investigational new…
Genmab gets EPKINLY FDA approval for diffuse large B-cell lymphoma
Danish biotech company Genmab has secured accelerated approval for EPKINLY (epcoritamab-bysp) from the US Food and Drug Administration…
Reflow Medical gets FDA commercial clearance for coraCatheters
Reflow Medical has obtained commercial clearance from the US Food and Drug Administration (FDA) for its coraCatheters range…
Dr. Reddy’s Laboratories launches FDA-approved Regadenoson Injection in the US market
Dr. Reddy’s Laboratories has launched its FDA-approved generic Regadenoson Injection in the US, offering a cost-effective alternative to Lexiscan for cardiac imaging.
Teva Pharmaceuticals, MedinCell get UZEDY FDA approval for schizophrenia
Teva Pharmaceuticals and MedinCell have bagged approval for UZEDY (risperidone) extended-release injectable suspension from the US Food and…
Zydus Lifesciences’ Menostar Transdermal System generic gets FDA final approval
Zydus Lifesciences has secured final approval from the UA Food and Drug Administration (FDA) for Estradiol Transdermal System…
Zydus Lifesciences wins FDA final approval for Isoproterenol HCL injection
Zydus Lifesciences has secured final approval for Isoproterenol Hydrochloride (HCL) Injection USP, 0.2 mg/mL and 1 mg/5 mL…
Narcan nasal spray becomes the first OTC naloxone product approved by the FDA for opioid overdose treatment
Emergent BioSolutions’ Narcan nasal spray is now FDA-approved for over-the-counter use. Find out how this could change the fight against opioid overdoses.
Can Lupin’s partnership with Caplin Steriles strengthen its position in the US injectable anesthetic market?
Lupin and Caplin Steriles secure FDA approval for generic Rocuronium Bromide Injection, targeting a $53M US anesthesia market segment.