Approvals

Roche gets FDA breakthrough therapy status for tiragolumab plus Tecentriq

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).

Israeli Ministry of Health authorises Covid-19 vaccine Moderna for use in Israel

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.

FDA grants ARX788 fast track designation for HER2-positive metastatic breast cancer

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 gives restricted emergency use approval for two Covid-19 vaccines

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.

US FDA approves Amphastar’s generic drug to treat severe hypoglycemia

The US Food and Drug Administration (FDA) has approved the first generic drug produced by Amphastar Pharmaceuticals to treat severe hypoglycemia.

Roche gets EC nod for Phesgo to treat HER2-positive breast cancer

Roche has secured approval from the European Commission (EC) for its Phesgo to treat early and metastatic HER2-positive breast cancer.

Pfizer and BioNTech receive authorisation in European Union for Covid-19 vaccine

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 gets FDA EUA for Covid-19 vaccine candidate mRNA-1273

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 receives FDA advisory committee vote supporting emergency use for Moderna’s vaccine against Covid-19 in US

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.