FDA grants tentative approval to Lupin for Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets
Lupin Limited, a leading global pharmaceutical company, has received tentative approval for its New Drug Application (NDA) for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets from ... Read More
Lupin receives FDA nod for Chlorpromazine Hydrochloride Tablets
Lupin Inc., a wholly-owned subsidiary of the global pharmaceutical major Lupin Limited, announced that it has received approval from the United States Food and Drug ... Read More
FDA approves Gilead’s Veklury for COVID-19 patients with severe renal impairment
Gilead Sciences said that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury (remdesivir) usage in COVID-19 ... Read More
FDA accepts review of Dr. Reddy’s biosimilar rituximab candidate, DRL_RI
Dr. Reddy's Laboratories, an Indian pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a ... Read More
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) has given the green light to its ... Read More
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 it has received a third Rare Pediatric ... Read More
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 the United States. This marks the first ... Read More
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 by the US Food and Drug Administration ... Read More
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 a once-daily oral treatment for individuals aged ... Read More
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, to be used for contrast-enhanced mammography (CEM). ... Read More