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FDA Statement on Efforts to Increase Availability of all Forms of Naloxone americanpharmaceuticalreview
September 24, 2019
Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can ...
Phoenix Molecular Designs Receives FDA Clearance to Begin PMD-026 Trial americanpharmaceuticalreview
September 24, 2019
Phoenix Molecular Designs (PhoenixMD) received clearance from the Food and Drug Administration (FDA) for PhoenixMD's Investigational New Drug (IND) application for its proprietary PMD-026.
Pii to Manufacture FDA-Approved Hormone Therapy Injection Drug Product contractpharma
September 24, 2019
Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO) headquartered in Hunt Valley, MD, will manufacture commercial supply of Fulvestrant Injection 250mg/5ml drug product ...
PIFELTRO, DELSTRIGO Receive FDA Approval for HIV-1 americanpharmaceuticalreview
September 23, 2019
Merck announced the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for PIFELTRO™ (in combination with other antiretroviral agents) and DELSTRIGO™ ...
FDA Grants Orphan Drug Designation to Reneo for REN001 americanpharmaceuticalreview
September 23, 2019
Reneo Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate ...
Hovione Announces Successful End-of-Phase 2 Meeting with the FDA americanpharmaceuticalreview
September 23, 2019
Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea.
FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma drugs
September 23, 2019
Merck, known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) approved the combination of Keytruda ...
FDA Approves Erleada (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) drugs
September 23, 2019
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Erleada (apalutamide) for the treatment of patients with ...
FDA Approves Rybelsus (semaglutide), the First Oral GLP-1 Analog Treatment for Adults with Type 2 Diabetes drugs
September 23, 2019
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose).
FDA approves combo drug to treat endometrial carcinoma biospectrumasia
September 20, 2019
According to the FDA, this review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

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