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News about "US FDA Approval"
Accord BioPharma has received US FDA approval for Immgolis and Immgolis Intri, the first golimumab biosimilars approved in the United States for rheumatoid arthritis and ulcerative colitis treatment.
US FDA Approval | 19/05/2026 | By News Bureau
Mabwell Secures FDA Clearance for 9MW5211 Clinical Trial Application
Mabwell receives US Food and Drug Administration (FDA) IND clearance for 9MW5211, a novel antibody therapy being developed for Inflammatory Bowel Disease (IBD) clinical studies.
US FDA Approval | 11/05/2026 | By News Bureau
Merck Wins FDA Approval for Once-Daily IDVYNSO (Doravirine/Islatravir)
IDVYNSO is approved for adults with virologically suppressed HIV-1 with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
US FDA Approval | 23/04/2026 | By News Bureau
The partnership among Orbicular Pharmaceutical Technologies, Gland Pharma and Apotex, achieves first ANDA approval with Competitive Generic Therapy designation, gaining six-month exclusivity for complex multivitamin injectable in the United States.
US FDA Approval | 16/04/2026 | By News Bureau | 153
Inventia Healthcare Launches Generic Dapagliflozin in US After FDA Approval
Inventia Healthcare has secured FDA approval for dapagliflozin tablets and begun Day-One commercialisation, expanding access to affordable diabetes and heart failure treatment in the US.
US FDA Approval | 09/04/2026 | By News Bureau | 155
Alembic Pharmaceuticals Secures US FDA Approval for Paroxetine ER Tablets
U.S. Food and Drug Administration grants final approval to Alembic’s sANDA for paroxetine extended-release tablets, used in treating depression and anxiety-related disorders.
US FDA Approval | 30/03/2026 | By News Bureau | 104
Novo Nordisk Wins FDA Approval for Wegovy HD to Advance Obesity Treatment
FDA approves Novo Nordisk’s Wegovy HD (semaglutide 7.2 mg), a higher-dose weekly injection delivering significant weight loss, supported by strong Phase III trial outcomes.
US FDA Approval | 21/03/2026 | By News Bureau | 127
BioVersys AG receives US Food and Drug Administration nod to include US patients in Phase III BV100 trial targeting drug-resistant pneumonia, marking progress in combating deadly hospital infections globally.
US FDA Approval | 18/03/2026 | By News Bureau
Shanghai UniXell Biotechnology. has received US Food and Drug Administration IND clearance for UX-GIP001, marking the first iPSC-derived allogeneic cell therapy to enter clinical trials for Epilepsy in the US.
US FDA Approval | 17/03/2026 | By News Bureau | 210
The US FDA has accepted Sun Pharma’s supplemental BLA for ILUMYA to treat active psoriatic arthritis in adults, with a decision expected by 29 October, 2026, potentially expanding its IL-23 inhibitor portfolio.
US FDA Approval | 17/03/2026 | By News Bureau
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