Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 28

Results For "U.S.-FDA"

291 News Found

Exelixis in-licenses second anti-cancer compound from Aurigene
Biotech | October 15, 2021

Exelixis in-licenses second anti-cancer compound from Aurigene

U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma


Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis
Biotech | October 09, 2021

Cyprium Therapeutics and Sentynl, a Zydus subsidiary announce positive data for CUTX-101, CuHis

The rolling submission to the U.S. FDA will begin in the fourth quarter of this year


Biocon launches Everolimus tablets in the US
Drug Approval | October 04, 2021

Biocon launches Everolimus tablets in the US

According to IQVIA, US sales of Everolimus (Afinitor) tablets were approximately US $ 675 million in the 12 months ending July 2021


MSD India launches 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL 9
Drug Approval | September 29, 2021

MSD India launches 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL 9

India’s first gender-neutral HPV vaccine to help reduce HPV -related disease burden in Indian girls, women and boys


Zebra Medical Vision receives clearance for Coronary Artery Calcium (CAC) solution
Digitisation | September 28, 2021

Zebra Medical Vision receives clearance for Coronary Artery Calcium (CAC) solution

The CAC solution cleared by the U.S. FDA analyses already existing non-gated CT scans and quantifies the coronary artery calcium in order to identify, stratify, and facilitate treatment pathways for patients with cardiovascular disease


Eisai initiates rolling submission for Biological Licence Application of Lecanemab
Biotech | September 28, 2021

Eisai initiates rolling submission for Biological Licence Application of Lecanemab

The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology


Tavneos (avacopan) approved for ANCA associated vasculitis in Japan
Drug Approval | September 28, 2021

Tavneos (avacopan) approved for ANCA associated vasculitis in Japan

It is the first orally administered therapy for the treatment of two types of ANCA-associated vasculitis approved in Japan


Flex Films launches F-UHB-M film to replace aluminium foil
Packaging | September 27, 2021

Flex Films launches F-UHB-M film to replace aluminium foil

A high-value proposition recyclable film packed with industry-leading barrier and metal bond performance, sustainability quotient and U.S. FDA compliant


Zydus Cadila receives final approval for Apremilast
Drug Approval | September 24, 2021

Zydus Cadila receives final approval for Apremilast

Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy


Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study
Biotech | September 21, 2021

Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study

In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year