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US green light for long-acting HIV regimen Cabenuva pharmatimes
January 25, 2021
The US Food and Drug Administration (FDA) has approved ViiV Healthcare and Janssen’s long-acting regimen for HIV-1 infection Cabenuva (cabotegravir, rilpivirine).
Impel NeuroPharma Announces NDA Acceptance of INP104 for Acute Migraine americanpharmaceuticalreview
January 25, 2021
Impel NeuroPharma announced the U.S. Food and Drug Administration (FDA) has accepted for review the company's 5O5(b)(2) New Drug Application (NDA) for INP104 for the acute treatment of migraine headaches with or without aura in adults.
FDA Publishes New Guidance on Protecting Participants in Bioequivalence Studies During COVID-19 americanpharmaceuticalreview
January 25, 2021
The U.S Food and Drug Administration (FDA) has published a new guidance for industry, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.
Alembic Pharma gets final nod from USFDA for Midodrine Hydrochloride Tablets expresspharma
January 25, 2021
Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.
Zydus Cadila gets US FDA nod for Liothyronine Sodium Tablets expresspharma
January 25, 2021
Zydus Cadila has received final approval from the USFDA to market Liothyronine Sodium Tablets USP, 5 meg, 25 meg, and 50 meg (US RLD: Cytomel Tablets).
Adamis submits IND application to FDA for Covid-19 treatment pharmaceutical-technology
January 22, 2021
Speciality biopharmaceutical company Adamis Pharmaceuticals has submitted an Investigational New Drug (IND) to the US Food and Drug Administration (FDA) for the use of Tempol to treat Covid-19.
FDA Grants Fast Track Designation to Padeliporfin ImPACT americanpharmaceuticalreview
January 21, 2021
Steba biotech announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for padeliporfin ImPACT for the treatment of adult patients with low-grade and unifocal high-grade Upper Tract Urothelial Cancer (UTUC).
FDA Releases Update on OTC Monograph Drug User Fee Program Implementation americanpharmaceuticalreview
January 20, 2021
The CARES Act, enacted in March 2020, amended the Federal Food, Drug, and Cosmetic Act to provide FDA authority to assess and collect annual facility fees from owners of qualifying OTC monograph drug facilities (in addition to fees for OTC monograph ...
Harpoon Therapeutics Granted Orphan Drug Designation for Multiple Myeloma Treatment americanpharmaceuticalreview
January 20, 2021
Harpoon Therapeutics announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma. HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC®) targets ...
Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets americanpharmaceuticalreview
January 20, 2021
Nostrum Laboratories is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level.

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