RedHill Biopharma announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy.
Moderna has secured conditional marketing authorisation (CMA) from the European Commission (EC) for mRNA vaccine called Covid-19 Vaccine Moderna.
Roche has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for tiragolumab plus Tecentriq (atezolizumab) to treat PD-L1-high non-small cell lung cancer (NSCLC).
Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that Israel’s Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna in Israel.
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.
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.
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