logo

FDA/Panel Decisions

Share

Science and technology company Merck KGaA (MKGAY.PK) announced Wednesday that the Independent Data Monitoring Committee (IDMC) recommended on Tuesday to discontinue the bintrafusp alfa clinical trial. Based on this recommendation, the Company has made the decision to discontinue the clinical trial, as...

AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo Company Limited (DSKYF.PK) said that the European Union has conditionally approved Enhertu or trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two...

AstraZeneca plc (AZN.L, AZN) and Daiichi Sankyo Co. Limited (DSKYF.PK) announced Monday that Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with previously treated HER2-positive advanced gastric cancer. The approval by the Food and Drug Administration...

PerkinElmer, Inc. (PKI) announced Thursday that its PerkinElmer New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to test individuals without symptoms or other reasons to suspect COVID-19 infection. For asymptomatic...

Boehringer Ingelheim and Eli Lilly and Company (LLY) announced the FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) for adults with heart failure with reduced ejection fraction. The sNDA was based on results from the EMPEROR-Reduced phase III trial. Jeff Emmick,...

Roche (RHHBY) said that the European Commission has approved single-dose, oral Xofluza for the treatment of uncomplicated influenza in patients aged 12 years and above. The European Commission has also approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and above....

Neoleukin Therapeutics, Inc. (NLTX) has received a clinical hold letter from the FDA related to the company's investigational new drug application to begin a phase 1 clinical program of its immunotherapeutic candidate, NL-201. The FDA has informed Neoleukin that it needs to develop a new assay. The FDA...

RedHill Biopharma Ltd. (RDHL) said Wednesday that the U.S. Food and Drug Administration or FDA has granted Fast Track designation to RHB-204 for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium...

Immuno-oncology company Marker Therapeutics, Inc. (MRKR) announced Tuesday that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on its Phase 2 trial investigating the safety and efficacy of MT-401, Marker's lead multi-tumor-associated antigen (MultiTAA)-specific T cell product...

AstraZeneca Plc. (AZN.L, AZN) announced Wednesday that its COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year. The UK Medicines and Healthcare products Regulatory Agency or MHRA has provided...

hypoglycemia dec29 The U.S. Food and Drug Administration approved the first generic drug to treat severe hypoglycaemia or dangerously low blood sugar levels, which could occur in patients with diabetes mellitus and who are using insulin treatment. Amphastar Pharmaceuticals' glucagon for injection USP, 1 mg/vial, packaged in an emergency kit, is the first-ever FDA approval of a generic version of rDNA Glucagon.

Moleculin Biotech, Inc., (MBRX), a clinical stage pharmaceutical company, said Tuesday that the U.S. Food and Drug Administration or FDA has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. The company's shares are rising more than 8 percent in pre-market activity. The...

Amphastar Pharmaceuticals, Inc. (AMPH) said the FDA has approved its Abbreviated New Drug Application for Glucagon for Injection Emergency Kit, 1 mg. Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid. The company plans to launch Glucagon for Injection...

The U.S. Food and Drug Administration has authorized the emergency use of Quanterix Corp.'s (QTRX) Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test. The test could be run on the Simoa HD-X Analyzer, a fully automated high-throughput immunoassay instrument. The Simoa Semi-Quantitative SARS-CoV-2...

AstraZeneca Plc. (AZN.L, AZN) and Merck & Co Inc. (MRK) said that Japan has approved Lynparza or olaparib for the treatment of three types of advanced cancer: ovarian, prostate and pancreatic cancer. The companies stated that the approvals authorize Lynparza for use as maintenance treatment after...

Follow RTT