FDA Approves Yimmugo (immune globulin intravenous, human-dira) to Treat Primary Immunodeficiencies

FDA Approves Pyzchiva (ustekinumab-ttwe), a Biosimilar to Stelara

drugs.com - 01/Jul 05:07

Basel, July 1, 2024 – Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration...

FDA Approves Tepylute (thiotepa) Ready-to-Dilute Injectable Formulation to Treat Breast Cancer and Ovarian Cancer

drugs.com - 28/Jun 22:06

CAMBRIDGE, Mass.--(BUSINESS WIRE) June 28, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced...

FDA Approves Sofdra (sofpironium) Topical Gel for the Treatment of Primary Axillary Hyperhidrosis

drugs.com - 20/Jun 04:06

Philadelphia and Phoenix US, 20 June 2024 -- Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased...

EG 427 receives US FDA clearance to initiate phase 1b/2a study of gene therapy, EG110A to treat NDO in spinal cord injury patients

pharmabiz.com - 26/Jun 00:00

EG 427, a biotechnology company leading the development of pinpoint DNA medicines for prevalent diseases in neurology based on its unique...

Monthly News Roundup - June 2024

drugs.com - 30/Jun 00:06

FDA Grants Expanded Approval to Skyrizi for Ulcerative Colitis On June 18th, the U.S. Food and Drug Administration (FDA) approved AbbVie’s...

FDA Approves KEYTRUDA + Chemo for Primary Advanced, Recurrent Endometrial Carcinoma

drugs.com - 21/Jun 22:55

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has approved Keytruda (pembrolizumab) plus chemotherapy as treatment for adult...

Genting and TauRx applying for UK, US regulators' approval for Alzheimer's drug

nst.com.my - 20/Jun 21:55

KUALA LUMPUR: Genting Bhd, along with its partner TauRx Pharmaceuticals Ltd., is currently seeking approval from both the United Kingdom's Medicines...

FDA Approves New Drug to Treat Alzheimer's, Kisunla

drugs.com - 19:07

TUESDAY, July 2, 2024 -- A new drug to treat Alzheimer's disease was approved by the U.S. Food and Drug Administration on Tuesday. In clinical trials,...

FDA Approves Ahzantive (aflibercept-mrbb), a Biosimilar to Eylea

drugs.com - 01/Jul 23:07

Planegg-Martinsried, Germany July 1, 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH...

Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

drugs.com - 26/Jun 04:06

BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...

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