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Merck seeks EUA for molnupiravir to treat Covid-19 in the US

Merck has submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) for its investigational oral antiviral medicine, molnupiravir (MK-4482/EIDD-2801), to treat Covid-19. Being developed in collaboration with Ridgeback Biotherapeutics, molnupiravir is an investigational, orally-administered...

Chugai Files for Additional Indications of Antibody Cocktail Ronapreve for Prophylaxis of COVID-19 and Treatment of Asymptomatic COVID-19

Chugai Pharmaceutical Co., Ltd. announced that it filed an application with the Ministry of Health, Labour and Welfare (MHLW) for approval of additional indications for the anti-SARS-CoV-2 monoclonal antibody RONAPREVE for prophylaxis of COVID-19 and treatment of asymptomatic...

Bharat Biotech’s Covaxin granted emergency use approval for kids aged 2-18 years

The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech's Covaxin for children in the 2-18 years age group. Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of...

Brii Bio Initiates Submission of EUA Filing to U.S. FDA for BRII-196/BRII-198, , its Monoclonal Antibody Combination Therapy for Non-Hospitalized COVID-19 Patients

Brii Biosciences Limited a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, announced the filing of an emergency use authorization (EUA) application for its investigational SARS-CoV-2 (virus that causes COVID-19)...

Glenmark launches Tavulus for COPD treatment in Spain, becoming one of the first companies to launch a bioequivalent version of the dry powder inhaler

Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company announced the launch of a bioequivalent version of Tiotropium Bromide dry powder inhaler (DPI) under the brand name Tavulusยฎ in Spain, for the treatment of chronic obstructive pulmonary disease (COPD). COPD...

Sweden, Denmark pause Moderna COVID-19 vaccine for younger age groups

Sweden and Denmark said they are pausing the use of Moderna's (MRNA.O) COVID-19 vaccine for younger age groups after reports of possible rare cardiovascular side effects. The Swedish health agency said it would pause using the shot for people born...

Moderna to Build State-of-the-Art mRNA Facility in Africa to Manufacture up to 500 Million Doses Per Year

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced it will build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50...

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