Browsing Tag
US FDA
379 posts
IPS HEART gets third FDA pediatric rare disease designation for ISX9-CPC
IPS HEART, a private cell therapy company developing treatments for Duchenne muscular dystrophy and heart failure, announced that…
Endo International introduces Noxafil generic version in US
Endo International has revealed that its Par Sterile Products division is now shipping posaconazole injection (18 mg/mL) in…
Zydus Lifesciences secures tentative FDA approval for Palbociclib Tablets
Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has announced that it has been granted tentative approval…
Pfizer gets LITFULO FDA approval for severe alopecia areata
Pfizer has announced that the US Food and Drug Administration (FDA) has granted approval to LITFULO (ritlecitinib) as…
Bayer gets Ultravist FDA approval for contrast-enhanced mammography
Bayer has received US Food and Drug Administration (FDA) approval for Ultravist (iopromide) injection, its iodine-based contrast agent,…
Lupin clinches FDA approval for generic Spiriva HandiHaler
Indian pharma titan Lupin has announced receiving approval from the US Food and Drug Administration (FDA) for its…
Zydus Lifesciences bags FDA final approval for generic of acne medication
Zydus Lifesciences has received the final approval from the US Food and Drug Administration (FDA) for Minocycline Hydrochloride…
FDA approves Cardio Flow Design’s iTFlow for enhanced cardiovascular diagnosis
The US Food and Drug Administration (FDA) has granted approval for iTFlow, a software solution developed by Cardio…
Zydus Lifesciences’ Diclofenac Sodium and Misoprostol Tablets gets FDA final approval
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to manufacture and market…
Granules India gets FDA approval for generic epilepsy drug Levetiracetam
Granules India has announced its receipt of approval from the US Food and Drug Administration (FDA) for its…