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To embed, copy and paste the code into your website or blog: Beginning this week, the U.S. Food and Drug Administration (“FDA”) ended its compliance and enforcement discretion policy with regard to certain human cell, tissue, and cellular and tissue-based products (“HCT/Ps”). HCT/P manufacturers without an FDA-approved marketing application may find themselves subject to FDA scrutiny under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and the Public Health Service Act (“PHS Act”). Firms will have to think hard about whether to submit investigational new drug applicatio...

Share this article Share this article NEW YORK, Feb. 23, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced today the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for their HT-001 product. The Pre-IND meeting was completed through written responses provided by the FDA Division of Dermatology and Dentistry on February 22, 2021. HT-001 is a topical formulation under development for the treatment of rash and skin disorders associated with initial and re...

Press release content from Business Wire. The AP news staff was not involved in its creation. Cortexyme Announces Leadership Appointments to Support Advancement of Atuzaginstat and Pipeline Expansion February 10, 2021 GMT SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Feb 10, 2021-- Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal trial in Alzheimer’s disease on schedule to be announced in Q4 2021 and a pipeline of therapeutics for degenerative diseases, today announced a series of leadership appointments to support the continued advancement and commercial planning of atuzaginst...

On December 18, 2020, the Food and Drug Administration approved osimertinib (TAGRISSO, AstraZeneca Pharmaceuticals LP) for adjuvant therapy after tumor resection in patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. Efficacy was demonstrated in a randomized, double-blind, placebo-controlled trial (ADAURA, NCT02511106) in patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC who had complete tumor resection, with or without prior adj...