Page 20 - Usfda

Lupin's Goa plant gets 7 observations from USFDA, firm unperturbed

Says confident of resolving matter, does not share nature of observations

Zydus Cadila gets USFDA nod to market depression treatment drug in US

Drug firm Zydus Cadila on Saturday said it has received approval from the US health regulator to market Vortioxetine Tablets, used to treat depression, in the American market.

Drug firms Granules India, Jubilant Cadista recall products in US market

Jubilant Cadista is a fully-owned subsidiary of Cadista Holdings Inc, which is a part of the Noida-based Jubilant Life Sciences Company.

Zydus Cadila gets USFDA's approval to market diabetes medication

Drug firm Zydus Cadila on Monday said it has received approval from the US health regulator to market Sitagliptin, a medicine indicated to treat diabetes.

Explained: What FDA full approval to Pfizer-BioNTech vaccine means

The research to develop a safe and effective Covid-19 vaccine was accelerated in 2020

US FDA grants full approval to Pfizer-BioNTech Covid vaccine

The FDA approved the two-dose vaccine for use in people over the age of 16.

Zydus Cadila gets USFDA nod for arthritis drug with 180-days exclusivity

Drug firm Zydus Cadila said it has received final approval from the US health regulator to market Tofacitinib extended-release tablets, used to treat rheumatoid arthritis, in the American market

USFDA's drug approvals for Indian firms halved in H1CY21: Report

ANDAs granted have halved in H12021, compared to pre-pandemic levels

Zydus Cadila gets tentative approval from USFDA for cancer drug

Shares of Cadila Healthcare, the listed entity of the group closed at Rs 531.35 per scrip on BSE, down 0.10 percent from its previous close.

Lupin gets tentative nod from USFDA to market partial-onset seizures drug

Drug firm Lupin on Monday said it has received tentative nod from the US health regulator to market its generic Brivaracetam tablets used for the treatment of partial-onset seizures

Top headlines: India sticks to growth forecast; Kerala struggles with Covid

Business Standard brings to you the top headlines on Friday

USFDA okays Biocon insulin Semglee as first interchangeable biosimilar drug

Semglee may now be substituted for Sanofi's Lantus by a pharmacist in the US

Caplin Point jumps 19%, hits record high; stock soars 37% in seven days

A combined 5.8 million equity shares, representing 7.6 per cent of the total equity of Caplin Point Laboratories, had changed hands on NSE and BSE till 12:56 pm

Zydus Cadila gets tentative approval from USFDA to market cancer drug

Drug firm Zydus Cadila on Wednesday said it has received tentative approval from the US health regulator to market Ibrutinib tablets used in the treatment of certain types of cancers.

Zydus gets USFDA nod to market generic HIV infection treatment tablets

The drug will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad

US FDA okays arthritis drug for treatment of hospitalised Covid-19 patients

The US Food and Drug Administration has issued an emergency use authorization for the drug Actemra (tocilizumab) -- used for arthritis -- for the treatment of hospitalised patients with Covid-19.

Glenmark Pharma gets USFDA approval for generic lung cancer drug

Glenmark Pharmaceuticals said it has received approval from the US health regulator to market Nintedanib capsules, used in the treatment of idiopathic pulmonary fibrosis and non-small cell lung cancer

Lupin gets warning letter from US health regulator for Somerset facility

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility, it said

Bharat Biotech to conduct additional clinical trials for USFDA nod

Timelines will be delayed; firm has received EUSs from 14 other countries

'BLA is standard process now': Bharat Bio on USFDA's EUA denial for Covaxin

The US regulator had earlier communicated that no new EUAs will be approved for Covid vaccines, says Hyderabad-based vaccine maker