Top

Category: Regulations


Cell and Gene Therapy, FDA, Industry, Regulations

FDA Lifts Partial Clinical Hold on PRS-343 Phase 1 Studies

January 19, 2021

Via: BioSpace

Pieris, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced that the U.S. Food and Drug Administration (FDA) has lifted the previously announced partial clinical […]


FDA, News, Regulations

FDA Vet Bumped Up to Top Spot by Biden Admin on Interim Basis

January 14, 2021

Via: BioSpace

Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is set to take over the top spot of the regulatory agency on an interim basis following the […]


FDA, Regulations

FDA Benches Immune-Boosting Cancer Therapy with Clinical Hold

January 8, 2021

Via: BioSpace

After submitting an IND less than a month ago, biopharma company Neoleukin was benched by the FDA with a clinical hold for their lead cancer immunotherapy candidate. Before approving the application, the FDA wants to see a new assay for […]


FDA, Industry, Regulations, Vaccines

FDA chief encourages states to open Covid vaccines to older Americans, other groups

January 8, 2021

Via: CNBC

The head of the Food and Drug Administration said Friday he is urging states to begin vaccinating lower-priority groups against Covid-19 as U.S. officials try to pick up the pace after a slower-than-expected initial rollout. FDA Commissioner Dr. Stephen Hahn […]


FDA, Regulations

FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer

January 4, 2021

Via: BioSpace

Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens in the […]


FDA, Regulations

FDA In Brief: FDA Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries

December 29, 2020

Via: BioSpace

“Providing women with access to safe medical devices to meet their health care needs is a top priority for the FDA. Today, we’ve taken two important steps on laparoscopic power morcellators as a result of listening to and acting on […]


Cell and Gene Therapy, FDA, Industry, Regulations

FDA Approves Myovant Drug as First-Ever Oral Hormone Therapy for Prostate Cancer

December 22, 2020

Via: BioSpace

One out of 9 men will be diagnosed with prostate cancer during his lifetime. The U.S. Food and Drug Administration (FDA) has now approved the very first oral drug to treat the millions of men affected. Myovant’s Orgovyx is aimed […]


FDA, Industry, Regulations, Vaccines

Moderna Wins FDA Authorization for COVID-19 Vax

December 21, 2020

Via: Contract Pharma

Moderna, Inc. received authorization from the U.S. FDA for the emergency use of mRNA-1273, Moderna’s vaccine against COVID-19 in individuals 18 years of age or older. The vaccine is now authorized for distribution and use under an Emergency Use Authorization […]


FDA, Industry, Regulations, Vaccines

A play-by-play of the FDA meeting on Moderna’s coronavirus vaccine

December 17, 2020

Via: Biopharma Dive

On Thursday, a committee of advisers to the Food and Drug Administration met for the second time in as many weeks to review an experimental coronavirus vaccine. The panel last week endorsed Pfizer and BioNTech’s shot, clearing the way for […]


FDA, News, Regulations

FDA authorizes Abbott’s rapid $25 Covid test for at-home use

December 16, 2020

Via: CNBC

The Food and Drug Administration on Wednesday announced that it has authorized Abbott Labs’ rapid Covid-19 test for at-home use, though doctors must prescribe the test for patients. The test, which is an antigen test that delivers results in about […]


FDA, Industry, Regulations, Vaccines

FDA scientists back safety, efficacy of Moderna’s coronavirus vaccine

December 15, 2020

Via: Biopharma Dive

Much like a review of Pfizer and BioNTech’s vaccine last week, the FDA’s analysis of Moderna’s shot is similarly positive. Results from a large trial testing the biotech’s vaccine in some 30,400 people showed two shots, spaced 28 days apart, […]


FDA, Industry, Regulations, Vaccines

6 things to know before FDA panel votes on Pfizer’s Covid vaccine today

December 10, 2020

Via: CNBC

A Food and Drug Administration panel is scheduled to vote Thursday on whether to recommend the approval of Pfizer and BioNTech’s coronavirus vaccine for emergency use. The nonbinding decision from the agency’s Vaccines and Related Biological Products Advisory Committee, an […]