New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
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FDA Approves Imuldosa (ustekinumab-srlf), a Biosimilar to Stelara

RALEIGH, N.C., Oct. 14, 2024 /PRNewswire/ -- Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug...

Tue Oct 15, 2024 08:20
FDA Approves Hympavzi (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors

NEW YORK--(BUSINESS WIRE) October 11, 2024 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding...

Sun Oct 13, 2024 05:34
FDA Approves Itovebi (inavolisib) for the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

South San Francisco, CA -- October 10, 2024 -- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved Itovebi (inavolisib), in combination with palbociclib (Ibrance) and fulvestrant, for the...

Fri Oct 11, 2024 02:54
FDA Approves Itovebi (inavolisib) for the Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

South San Francisco, CA -- October 10, 2024 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved ItovebiTM (inavolisib), in combination with palbociclib...

Fri Oct 11, 2024 01:53
U.S. Food and Drug Administration Approves Perioperative Treatment of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable Non-Small Cell Lung Cancer (NSCLC)

PRINCETON, N.J.--(BUSINESS WIRE) Oct 03, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo ® (nivolumab) for the treatment of adult patients with resectable (tumors ≥4...

Mon Oct 7, 2024 03:04
FDA Grants Traditional Approval to Retevmo (selpercatinib) for Medullary Thyroid Cancer with a RET Mutation

On September 27, 2024, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer...

Wed Oct 2, 2024 08:16

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