Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 61
Drug Approval
Drug Approval | 06 December 2021

Lilly's bamlanivimab with etesevimab authorized for emergency use in Covid-19 patients under 12

Expanded EUA includes both treatment of patients with Covid-19 and post-exposure prophylaxis (PEP) in high-risk pediatric and infant patients

Drug Approval
Drug Approval | 05 December 2021

Morpen gets U.S. FDA approval for Fexofinadine

Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever

Drug Approval
Drug Approval | 03 December 2021

Unichem Labs gets ANDA approval for schizophrenia medicine

The product will be commercialized from Unichem's Ghaziabad plant

Drug Approval
Drug Approval | 03 December 2021

Biocon Pharma receives ANDA approval for Mycophenolic acid

This further adds to Biocon’s portfolio of vertically integrated complex drug products

Drug Approval
Drug Approval | 30 November 2021

U.S. FDA approves Cytalux injection for identifying ovarian cancer during surgery

It is the first targeted fluorescent imaging agent that illuminates ovarian cancer intraoperatively, enabling the detection of more cancer for removal

Drug Approval
Drug Approval | 26 November 2021

Aadi Bioscience secures U.S FDA approval of its first product Fyarro

Fyarro is the first and only approved therapy for adults for the treatment of malignant PEComa in adults

Drug Approval
Drug Approval | 25 November 2021

ICMR approves Meril’s Rapid Antigen Test kit

The company is marketing the kit under the brand name CoviFind and it can detect the infection in 15 minutes

Drug Approval
Drug Approval | 24 November 2021

U.S. FDA approves first treatment for drug-resistant post-transplant infection

The approval is for Cytomegalovirus, a type of Herpes virus

Drug Approval
Drug Approval | 23 November 2021

Boehringer Ingelheim gets CDSCO nod for Jardiance

Jardiance is the first SGLT2-inhibitor therapy to prove reduction in risk of cardiovascular death in people with type-II diabetes and established cardiovascular disease

Drug Approval
Drug Approval | 23 November 2021

U.S. FDA approves Alembic’s Formoterol Fumarate inhalation solution

The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies

Drug Approval
Drug Approval | 23 November 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)

Drug Approval
Drug Approval | 22 November 2021

European Commission approves Roche’s Gavreto

Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people with RET fusion-positive advanced NSCLC

Drug Approval
Drug Approval | 22 November 2021

Amneal gets approval for Difluprednate ophthalmic emulsion

The company is moving towards complex and more differentiated products

Drug Approval
Drug Approval | 20 November 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years

Drug Approval
Drug Approval | 20 November 2021

U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism

Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth

Drug Approval
Drug Approval | 19 November 2021

Natco launches Tipanat tablets in India

It is used for the treatment of advanced colorectal and gastric cancer

Drug Approval
Drug Approval | 18 November 2021

Zydus Cadila receives U.S.FDA approval for leukaemia injection

Nelarabine is in a class of medications called antimetabolites

Drug Approval
Drug Approval | 17 November 2021

Alembic JV receives final approval for Mupirocin cream

The cream has an estimated market size of US $ 28 million for twelve months ending Jun 2021 according to IQVIA

Drug Approval
Drug Approval | 17 November 2021

U.S FDA authorises EaseVRx, immersive virtual reality for pain relief

EaseVRx employs the principles of cognitive behavioural therapy and other behavioural therapy techniques for the reduction of pain and pain interference

Drug Approval
Drug Approval | 15 November 2021

Zydus Cadila receives tentative approval for IBS tablets

The group now has 324 approvals and has so far filed over 400 ANDAs

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