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Results For "U.S"

1563 News Found

Hikal announces USFDA audit with zero observations
Drug Approval | May 16, 2023

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites


USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause
Drug Approval | May 13, 2023

USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause


Lilly allocates additional US $50 million to Social Impact Venture Capital portfolio
News | May 12, 2023

Lilly allocates additional US $50 million to Social Impact Venture Capital portfolio

The additional $50 million will go towards venture capital firms that specialize in near- and long-term healthcare solutions for patients in low- and middle-income countries


Briefs: Dr. Reddy's Laboratories
News | May 06, 2023

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation


Indoco receives EIR for its Plant I manufacturing facility in Goa
Drug Approval | May 04, 2023

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.


USFDA Advisory Committee votes  n Lynparza plus Abiraterone and Prednisone  for prostate cancer
Drug Approval | May 03, 2023

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients


Lilly's Lebrikizumab shows improved face or hand dermatitis
Clinical Trials | May 02, 2023

Lilly's Lebrikizumab shows improved face or hand dermatitis

Lebrikizumab is an investigational high-affinity and potent IL-13 inhibitor being studied in adult and adolescent patients


CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma
Drug Approval | May 02, 2023

CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma


Sun Pharma launches CEQUA, a novel therapy for Dry Eye Disease in India
News | April 25, 2023

Sun Pharma launches CEQUA, a novel therapy for Dry Eye Disease in India

CEQUA is the first dry eye treatment available in India that is delivered with nanomicellar (NCELL) technology


USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013
Drug Approval | April 24, 2023

USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013

This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology