Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1.

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Clinical Trials Regulations Production FDA 130

New Drug Approvals

DECEMBER 24, 2023

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. 88 (12): 5389–5398. PMID 35869634.

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Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

Biosimilars 52

Biosimilars FDA FDA Approval Small Molecule 52

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] July 2022). 1] It is taken by mouth. [1] 401 (10383): 1159–1171.

FDA 57

FDA FDA Approval International Pharmacokinetics 57

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. from 2021 to 2022, up to $625 million. Ricciardi M.J. Will Bedingfield.

DNA 52

DNA RNA Engineering Licensing 52

FDA Law Blog: Biosimilars

MAY 21, 2024

Even though President Joe Biden had asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law” in October 2022 , we also wondered how the Department of Justice (“DOJ”) and DEA would receive the HHS recommendation. Basis at 24.

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Regulations FDA Licensing Licensing 69