Ambrx announced that the US 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 metastatic setting.
India's Central Drugs Standard Control Organisation (CDSCO) has given the restricted emergency use approval for Covid-19 vaccines of Serum Institute of India and Bharat Biotech.
The US Food and Drug Administration (FDA) has approved the first generic drug produced by Amphastar Pharmaceuticals to treat severe hypoglycemia.
Roche has secured approval from the European Commission (EC) for its Phesgo to treat early and metastatic HER2-positive breast cancer.
The US Food and Drug Administration (FDA) has accepted Hepion Pharmaceuticals’ investigational new drug (IND) application for its CRV431, a novel cyclophilin inhibitor, to treat Covid-19.
Pfizer and BioNTech SE (Nasdaq: BNTX) announced today that the European Commission (EC) has granted a conditional marketing authorization (CMA) to Pfizer and BioNTech for COMIRNATY® (also known as BNT162b2), for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older.
Moderna’s mRNA-1273 vaccine has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for the prevention of Covid-19.
Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, confirmed that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for the Company’s COVID-19 vaccine candidate, mRNA-1273. 20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained.
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ).
GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its Benlysta (belimumab) to treat adult patients with active lupus nephritis (LN) who are securing standard therapy.
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