FDA Approves Tryvio (aprocitentan) for the Combination Treatment of Resistant Hypertension

RADNOR, Pa., March 20, 2024 /PRNewswire/ -- Idorsia Pharmaceuticals U.S. Inc. announced today that the US Food and Drug Administration (FDA) has approved Tryvio™ (aprocitentan) for the treatment of hy

Latest News NDA News 304
Read All

FDA Approves Lenmeldy (atidarsagene autotemcel) for Children with Metachromatic Leukodystrophy

TOKYO and LONDON and BOSTON, March 18, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients arou

Latest News NDA News 252
Read All

FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

CONSHOHOCKEN, Pa., March 14, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatiti

Latest News NDA News 261
Read All

FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Dr

Latest News NDA News 285
Read All

FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to Actemra

March 7, 2024 -- Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditio

Latest News NDA News 302
Read All

FDA Approves Jubbonti (denosumab-bddz), an Interchangeable Biosimilar to Prolia

Basel, March 5, 2024 -- Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Jubbonti, (denosumab-bbdz), an interchang

Latest News NDA News 441
Read All

FDA Approves Wyost (denosumab-bddz), an Interchangeable Biosimilar to Xgeva

Basel, March 5, 2024 -- Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost (denosumab-bbdz), an interchangeabl

Latest News NDA News 359
Read All

FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines

NEWPORT BEACH, Calif., March 4, 2024 /PRNewswire/ -- Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.)

Latest News NDA News 709
Read All

FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to to Humira

REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEV

Latest News NDA News 356
Read All

FDA Grants Accelerated Approval for Amtagvi (lifileucel) for the Treatment of Advanced Melanoma

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor infi

Latest News NDA News 462
Read All

FDA Approves Aurlumyn (iloprost) as the First Medication to Treat Severe Frostbite

February 14, 2024 -- The U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. "This approva

Latest News NDA News 409
Read All

FDA Approves Eohilia (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis

OSAKA, Japan and CAMBRIDGE, Massachusetts, February 12, 2024 -- Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Eohilia (budesonide oral suspen

Latest News NDA News 484
Read All
News
- CLINIEXPERT -
Int'l Clinical Service Expert

We are the leader
Because of our professionism