Regulation

CURE Pharmaceutical receives FDA approval for IND application for erectile dysfunction product CUREfilm Blue

CURE Pharmaceutical Holding, a technology focused, vertically integrated drug delivery and product development company in the pharmaceutical and health & wellness space, announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for its product CUREfilm Blue, an oral soluble film of sildenafil citrate (the active ingredient present in Viagra®1) for the treatment of erectile dysfunction (ED).

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.

FDA accepts Hepion’s IND application for CRV431 to treat Covid-19

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 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.