FDA Approvals

Submission status for BIOGEN INC's drug ZURZUVAE (SUPPL-3) with active ingredient ZURANOLONE has changed to 'Approval' on 04/20/2026. Application Category: NDA, Application Number: 217369, Application Classification: Labeling

Submission status for PROVENTION BIO INC's drug TZIELD (SUPPL-13) with active ingredient TEPLIZUMAB-MZWV has changed to 'Approval' on 04/20/2026. Application Category: BLA, Application Number: 761183, Application Classification:

For Immediate Release: March 28, 2025 Today, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors (neutralizing antibodies).“Today’s approval of Qfitlia is significant for patients wi

For Immediate Release: March 11, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:Today, the FDA published a General Correspondence Letter issued to Mid-Link Technology Testing Co., Ltd. The FDA is vigilant in ensuring data submitted to the FDA can be relied upon to assess the effectiveness, safety, or risk of a device. The FDA has noted an incr

For Immediate Release: February 28, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA approved Odactra to include use in individuals 5 through 11 years of age to treat house dust mite induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis). Odactra is an allergen extract immunotherapy

For Immediate Release: February 21, 2025 Today, the U.S. Food and Drug Administration approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.“The FDA is dedicated to supporting new drug development for rare diseases including very rare metabolic diseases like cerebrotendinous xanthomato

For Immediate Release: February 14, 2025 Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Merilog, a rapid-acting human insulin analog, is the first rapid-acting insulin biosimilar product approved by the FDA. As a rapid-acting insulin, Meri

For Immediate Release: January 30, 2025 Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.  Journavx is the first dr

For Immediate Release: December 13, 2024 Today, the U.S. Food and Drug Administration approved Crenessity (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia (CAH).“Today’s approval provides an important advance for patients with classic con

For Immediate Release: December 06, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Thursday, the FDA published the draft guidance, “Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics,” which proposes updates to certain agency policies and procedures regarding accelerated approval. Topics addressed by this

Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-6) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/25/2024. Application Category: NDA, Application Number: 215973, Application Classification: Efficacy

Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-8) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/25/2024. Application Category: NDA, Application Number: 215974, Application Classification: Efficacy

Submission status for BRIDGEBIO PHARMA INC's drug ATTRUBY (ORIG-1) with active ingredient ACORAMIDIS has changed to 'Approval' on 11/22/2024. Application Category: NDA, Application Number: 216540, Application Classification: Type 1 - New Molecular Entity

Submission status for IMMUNOMEDICS INC's drug TRODELVY (SUPPL-58) with active ingredient SACITUZUMAB GOVITECAN-HZIY has changed to 'Approval' on 11/22/2024. Application Category: BLA, Application Number: 761115, Application Classification:

Submission status for HERON THERAPS INC's drug ZYNRELEF KIT (SUPPL-18) with active ingredient BUPIVACAINE; MELOXICAM has changed to 'Approval' on 11/21/2024. Application Category: NDA, Application Number: 211988, Application Classification: Labeling

Submission status for AMGEN INC's drug REPATHA (SUPPL-44) with active ingredient EVOLOCUMAB has changed to 'Approval' on 11/20/2024. Application Category: BLA, Application Number: 125522, Application Classification:

Submission status for SYNDAX PHARMACEUTICALS INC's drug REVUFORJ (ORIG-1) with active ingredient REVUMENIB has changed to 'Approval' on 11/15/2024. Application Category: NDA, Application Number: 218944, Application Classification: Type 1 - New Molecular Entity

Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-9) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/13/2024. Application Category: NDA, Application Number: 215973, Application Classification: Manufacturing (CMC)

Submission status for GILEAD SCIENCES INC's drug SUNLENCA (SUPPL-9) with active ingredient LENACAPAVIR SODIUM has changed to 'Approval' on 11/13/2024. Application Category: NDA, Application Number: 215974, Application Classification: Labeling

For Immediate Release: November 14, 2024 The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency. “Clinical advancements in the f