Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 24

Results For "U.S.-FDA"

246 News Found

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


Technology to distinguish between bacterial and viral infections cleared
Medical Device | September 21, 2021

Technology to distinguish between bacterial and viral infections cleared

MeMed BV is a first-of-its-kind test that decodes the immune response to accurately distinguish between bacterial or viral infections within minutes


Glenmark receives ANDA approval for treatment of acne
Drug Approval | September 21, 2021

Glenmark receives ANDA approval for treatment of acne

Clindamycin Phosphate Foam, 1% is the generic version of Evoclin Foam, 1%


Promising prospects for Indian pharma: CLSA
News | September 17, 2021

Promising prospects for Indian pharma: CLSA

CLSA, a capital market and investment group organised an Investors’ Forum where five Indian pharma companies participated. Excerpts from the report


RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant
Drug Approval | August 26, 2021

RedHill Biopharma's Opaganib demonstrates strong inhibition of COVID-19 Delta variant

Opaganib, a leading novel small molecule investigational oral pill in development for Covid-19, is a unique host targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of the disease


Biocon Q1FY22 revenue up 6% at Rs 1,808 Cr
News | July 23, 2021

Biocon Q1FY22 revenue up 6% at Rs 1,808 Cr

Q1 FY22 consolidated revenue grew 6% to Rs. 1,808 crore from Rs. 1,712 crore in Q1 FY21. Q1 FY22 Net Profit was Rs. 84 crore (vs. Rs. 149 crore in Q1 FY21).