FDA approves Genentech’s Vabysmo Prefilled Syringe (PFS) for three leading causes of vision loss
Vabysmo PFS is reportedly the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal…
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Browsing Tag
drug approval
Alembic Pharmaceuticals receives five US FDA product approvals in Q1FY25
Receives 3 final and 2 tentative product approvals thus far in Q1FY25
Jardiance by Boehringer Ingelheim approved in India for the treatment of adults with CKD
This indication approval allows the nephrologists and cardiologists to use Jardiance 10mg tablets for the treatment of CKD in…
AstraZeneca receives CDSCO approval to market its inhalation aerosol
The pressurised metered dose inhaler is recommended for the treatment and maintenance of patients with Chronic Obstructive…
Karuna Therapeutics’ NDA for KarXT accepted by USFDA
If approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades
Aurobindo Pharma gets USFDA nod for HIV drug
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Darunavir…
Lupin receives approval from USFDA for Pirfenidone tablets
This product will be manufactured at Lupin’s Pithampur facility in India
Lupin receives approval from TGA Australia for Tiotropium dry powder
The product will be manufactured at Lupin’s Pithampur facility in India
Lupin receives USFDA approval for Chlorpromazine Hydrochloride tablets
This product will be manufactured at Lupin’s Somerset facility in the U.S.
EMA accepts Intas Pharma’s MAA for DMB-3115
herapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global phase III