Browsing Tag
US Food and Drug Administration
348 posts
280Bio initiates Phase 1 clinical study for YL-17231 after FDA approval
In a significant breakthrough for 280Bio, Inc., a clinical-stage biotechnology company, the US Food and Drug Administration (FDA)…
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…
Lupin gains tentative FDA approval for Dolutegravir Tablets generic
Indian pharmaceutical company Lupin announced that the US Food and Drug Administration (FDA) has granted tentative approval for…
Zydus Lifesciences gets FDA final approval for Oxcarbazepine tablets
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to produce and sell…
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…