News about "USFDA approval"

Travere Secures Full US FDA Approval for FILSPARI

Travere Therapeutics secures full US FDA approval for FILSPARI (sparsentan) to treat FSGS, expanding access to over 100,000 patients with a therapy aligned with KDIGO guidelines.

USFDA Approval | 15/04/2026 | By News Bureau

Lupin Secures US FDA Approval for Dapagliflozin Tablets in US

Lupin secures US FDA approval for Dapagliflozin Tablets 5 mg and 10 mg in the US, bioequivalent to Farxiga.

USFDA Approval | 08/04/2026 | By News Bureau

Alembic Pharmaceuticals Gains USFDA Approval for Dapagliflozin Tablets ANDA

Alembic Pharmaceuticals receives USFDA approval for Dapagliflozin Tablets ANDA, gaining eligibility for 180-day shared generic drug exclusivity and strengthening its diabetes portfolio.

USFDA Approval | 07/04/2026 | By News Bureau

Cipla USA Secures USFDA Approval for Generic Nintedanib to Treat Pulmonary Fibrosis

Cipla USA receives USFDA approval for generic Nintedanib capsules, expanding access to treatment for patients with idiopathic pulmonary fibrosis in the United States.

USFDA Approval | 06/04/2026 | By News Bureau |  120

BioXcel Therapeutics Announces FDA Acceptance of Supplemental NDA for IGALMI

BioXcel Therapeutics receives FDA acceptance for supplemental NDA of IGALMI, targeting acute agitation in bipolar disorder and schizophrenia for potential at-home treatment use.

USFDA Approval | 02/04/2026 | By News Bureau

Galderma Wins FDA Approval for Restylane Contour for Temple Hollowing

FDA approves Galderma’s Restylane Contour for temple hollowing, expanding its use with natural-looking results lasting up to 18 months and high patient satisfaction.

USFDA Approval | 24/03/2026 | By News Bureau

FDA Approves Rhythm Pharma's IMCIVREE for Acquired Hypothalamic Obesity

Rhythm Pharmaceuticals has received US Food and Drug Administration (FDA) approval for IMCIVREE, the first and only treatment for acquired Hypothalamic Obesity (HO), supported by phase-III data showing a 18.4 percent placebo-adjusted BMI reduction in patients aged four years and older.

USFDA Approval | 20/03/2026 | By News Bureau

US FDA Approves GSK's AREXVY for At-Risk Adults Aged 18 to 49 Years

The US FDA has approved GSK’s RSV vaccine, AREXVY, for adults aged 18–49 who are at increased risk of severe RSV infection, expanding protection to an estimated 21 million at-risk individuals in this age group.

USFDA Approval | 16/03/2026 | By News Bureau

FDA Clears Novo Nordisk's Sogroya for Three New Paediatric Uses

The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Sogroya for three additional paediatric indications, expanding its use in children aged 2.5 years and older and reinforcing its position as the only once-weekly, long-acting growth hormone with the broadest approved label.

USFDA Approval | 02/03/2026 | By News Bureau |  109

US FDA Clears Anuh Pharma Facility with No Form 483 Observations

The Tarapur facility of Anuh Pharma is already an EUGMP/ WHO pre-qualified approved manufacturing facility with nine API’s blocks and two intermediate block with total capacity of 2400 MTPA.

USFDA Approval | 11/02/2026 | By News Bureau |  123