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Category: FDA


FDA, Regulations

FDA May be Getting Tougher, but Gives Trodelvy Nod for Triple-Negative Breast Cancer

April 9, 2021

Via: BioSpace

There has been discussion that the U.S. Food and Drug Administration (FDA) is getting tougher, and they are running an industry-wide evaluation of accelerated approvals. However, today the agency granted full approval to Gilead Sciences’ Trodelvy (Sacituzumab govitecan-hziy) for adults […]


Biotech, FDA, Industry, Regulations

FDA Provides Positive Feedback on Tetra Bio-Pharma’s Application for ARDS-003 Clinical Development in COVID-19 Patients

April 5, 2021

Via: BioSpace

Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX:TBP)(OTCQB:TBPMF)(FRA:JAM1), a biopharmaceutical pioneer in immunomodulator drug discovery and development is pleased to announce that the U.S. Food and Drug Administration (FDA) has favorably reviewed the preclinical data package and clinical development plan […]


Cell and Gene Therapy, FDA, Industry, Regulations

How to gear up for more stringent gene and cell therapy regulations

April 1, 2021

Via: EPM Magazine

In January 2020, the US Food and Drug Administration (FDA) published a series of seven guidances regarding cell and gene therapy. These have not come too soon, given some much-publicised regulatory rejections. For example, the FDA turning down the Biologics […]


FDA, Regulations

FDA advisers reassert case against approval of Biogen’s Alzheimer’s drug

March 31, 2021

Via: Biopharma Dive

One of the most important decisions in the history of the Food and Drug Administration is quickly approaching. By early June, the agency should have a verdict on whether to approve aducanumab, a potentially first-of-its-kind treatment for Alzheimer’s disease that […]


Clinical Trials, FDA, Regulations, Research and Development

FDA green light for BMS, bluebird bio’s CAR-T therapy Abecma in multiple myeloma

March 30, 2021

Via: Pharma Times

Abecma (idecabtagene vicleucel; ide-cel) has been cleared for use in adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. In the […]


FDA, Regulations

Is the FDA Getting Tougher on Drug Applications?

March 26, 2021

Via: BioSpace

It’s already been reported that the U.S. Food and Drug Administration (FDA) is running an industry-wide evaluation of its accelerated approvals. These approvals were typically granted for drugs with a high unmet need and require the companies to conduct post-marketing […]


FDA, Regulations

FDA Cites Safety Concerns Over Pfizer and Lilly’s Osteoarthritis Drug Tanezumab

March 22, 2021

Via: BioSpace

A newly published briefing document from the U.S. Food and Drug Administration (FDA) cites critical safety concerns with Pfizer and Eli Lilly’s anti-NGF osteoarthritis drug tanezumab, despite the fact that clinical trials have demonstrated the agent can help patients with […]


FDA, Regulations

FDA rejects rare disease drug, asks for prefilled syringe info

March 16, 2021

Via: FiercePharma

The FDA has rejected PharmaEssentia’s request for approval of a treatment for a rare blood cancer. PharmaEssentia needs to provide more information about the instructions for the prefilled syringes used to administer the pegylated interferon. Ropeginterferon alfa-2b, which is sold […]


FDA, News, Regulations

Visus Therapeutics Announces FDA Acceptance of IND for Presbyopia-Correcting Eye Drop

March 16, 2021

Via: BioSpace

Visus Therapeutics Inc. (the “Company”), a clinical-stage pharmaceutical company in pursuit of developing the world’s first presbyopia-correcting eye drop with the potential to last a minimum of eight hours, today announced that the U.S. Food and Drug Administration (FDA) has […]


FDA, Regulations

FDA Grants Fast Track Designation to Spectrum Pharmaceuticals’ Poziotinib

March 11, 2021

Via: BioSpace

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer (NSCLC) […]


FDA, Regulations

Alkermes Announces FDA Orphan Drug Designation for Nemvaleukin Alfa for Treatment of Mucosal Melanoma

March 11, 2021

Via: BioSpace

Alkermes plc (Nasdaq: ALKS) today announced that nemvaleukin alfa (“nemvaleukin”, formerly referred to as ALKS 4230), the company’s investigational engineered interleukin-2 (IL-2) variant immunotherapy, has been granted orphan drug designation for the treatment of mucosal melanoma by the U.S. Food […]


FDA, News, Regulations

Don’t Use Veterinary Drug Ivermectin Against COVID, FDA Warns

March 9, 2021

Via: Drugs.com

Desperate for a treatment against COVID-19, some Americans have reached for an anti-parasitic drug aimed at animals, with serious consequences, the U.S. Food and Drug Administration warns. “Never use medications intended for animals on yourself. Ivermectin preparations for animals are […]