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OncoSec Medical Incorporated (ONCS) announced the FDA has approved the Investigational New Drug application for a first-in-human phase 1 trial for CORVax12, a DNA-encodable vaccine against SARS-CoV-2. The company is developing the DNA-encodable vaccine with Providence Cancer Institute, a part of Providence...

Regeneron Pharmaceuticals Inc. (REGN) announced that the U.S. Food and Drug Administration has accepted for priority review the supplemental Biologics License Application or sBLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc). The sBLA is to treat patients with first-line locally advanced or metastatic...

Japan-based Astellas Pharma Inc. (ALPMY) said Wednesday that the U.S. Food and Drug Administration or FDA has granted Fast Track designation for the development of ASP5354, based on non-clinical and clinical data. ASP5354, an optical imaging agent being developed by Astellas, is being investigated...

British drug major AstraZeneca Plc. (AZN.L, AZN) announced Wednesday that China's National Medical Products Administration or NMPA has approved Forxiga's (dapagliflozin) cardiovascular outcomes benefit. NMPA has updated the label for Forxiga to include data from the DECLARE-TIMI 58 Phase III trial...

SQI Diagnostics Inc.(SQD.V, SQIDF), a Canadian precision medicine company that develops rapid diagnostic testing, on Monday announced confirmation from the U.S. FDA that Emergency Use Authorization or EUA submission is acceptable for its three novel COVID diagnostic tests. SQI is accelerating the...

fda july23 26oct20 The FDA has decided to delay its decision on Spectrum Pharmaceuticals' (SPPI) Rolontis, which was due on October 24, as the regulatory agency has been unable to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel curbs.

fdagilead oct23 The U.S. Food and Drug Administration (FDA) has gone ahead with the approval of antiviral drug remdesivir as first treatment for COVID-19, notwithstanding last week's findings by the World Health Organization (WHO) that the drug is not effective for COVID-19 treatment. Thursday, Gilead Sciences announced that the FDA approved remdesivir, sold under the brand name Veklury.

Astellas Pharma Inc. (ALPMY, ALPMY) announced that the FDA has granted Fast Track designation for the development of ASP0367/MA-0211 as a potential treatment for primary mitochondrial myopathies. There is no FDA-approved treatment for primary mitochondrial myopathies, a rare disease with a high unmet...

British drug major AstraZeneca Plc. (AZN.L, AZN) announced Tuesday that its Tagrisso (osimertinib) has received acceptance for its supplemental New Drug Application or sNDA and has also been granted Priority Review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer. The...

Centogene N.V. (CNTG) said the FDA has issued Emergency Use Authorization for CentoSure, the company's SARS-CoV-2 RT-PCR test. CentoSure SARS-CoV-2 RT-PCR assay is a real-time test based on the reverse transcription polymerase chain reaction for the qualitative detection of SARS-CoV-2, the virus causing...

AstraZeneca Plc. (AZN.L, AZN) announced Monday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended Forxiga (dapagliflozin) for an indication extension of its marketing authorisation in the European Union. The recommendation is for the treatment...

Roche (RHHBY) announced the FDA has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia in adults 75 years or older, or who have comorbidities that preclude use of intensive...

Swiss drug major Novartis AG (NVS) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of Leqvio (inclisiran) for the treatment of adults with hypercholesterolemia...

Merck & Co. Inc. (MRK) announced Thursday that Health Canada has approved its anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma or HNSCC as monotherapy. The treatment is for adult patients whose tumours...

ImmunityBio, Inc. has received authorization from the FDA to begin a phase I clinical trial of hAd5-COVID-19, the company's COVID-19 vaccine candidate. The company plans launching a phase I trial in the current month with adult subjects up to age 55. ImmunityBio, Inc. is a late-clinical-stage immunotherapy...

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