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Results For "Food-and-Drug-Administration"

1255 News Found

Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder
Drug Approval | March 27, 2024

Ultomiris approved in the US for the treatment of adults with neuromyelitis optica spectrum disorder

First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+


FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension
Drug Approval | March 27, 2024

FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension

WINREVAIR is a breakthrough biologic for this rare, progressive disease


AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer
Clinical Trials | March 23, 2024

AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer

Combination shows consistent benefit across prespecified post-progression outcomes


Briefs: Concord Biotech and Neuland Laboratories
Drug Approval | March 23, 2024

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483


USFDA grants ODD to Cevidoplenib for immune thrombocytopenia
News | March 23, 2024

USFDA grants ODD to Cevidoplenib for immune thrombocytopenia

Oscotec has successfully completed phase 2 study in patients with chronic ITP last year


Zydus receives tentative approval from USFDA for Letermovir Tablets
Drug Approval | March 23, 2024

Zydus receives tentative approval from USFDA for Letermovir Tablets

Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)


Zydus receives USFDA approval for Finasteride and Tadalafil capsules
Drug Approval | March 18, 2024

Zydus receives USFDA approval for Finasteride and Tadalafil capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India


Zydus receives USFDA final approval for chlorpromazine hydrochloride injection
Drug Approval | March 14, 2024

Zydus receives USFDA final approval for chlorpromazine hydrochloride injection

Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders


European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
Drug Approval | March 13, 2024

European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease

PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally


Merck completes acquisition of Harpoon Therapeutics
News | March 12, 2024

Merck completes acquisition of Harpoon Therapeutics

Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager