After detailed deliberation, the Central Drug Authority recommended that the firm should submit additional data and information.

Govt panel seeks additional data from Serum Institute on Covovax

Nov 28, 2021

SII had put in an application to the DCGI in October for a grant of market authorisation of Covovax for restricted use in emergency situations.

ITC begins clinical trials of nasal spray

ITC begins clinical trials of nasal spray for COVID-19 prevention

Nov 25, 2021

ITC plans to market the nasal spray under the Savlon brand once it gets all the requisite regulatory approvals.

Jardiance received approval from the US Food and Drug Administration (FDA) earlier this year in August for the heart failure indication.

CDSCO approves German pharma firm's drug; to help reduce cardiovascular deaths in India

Nov 22, 2021

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.

The company is recalling 73,957 bottles of 5 mg strength and 36,786 bottles of 20 mg strength, the US health regulator stated

Sun Pharma recalls products in US market

Nov 21, 2021

The US arm of the domestic pharma major is recalling Tadalafil tablets in the American market, according to the latest enforcement report of the US Food and Drug Administration (USFDA).

Decitabine is used to treat myelodysplastic syndromes, certain types of blood or bone marrow cancer

Zydus Cadila receives USFDA approval to market generic cancer drug in US

Nov 20, 2021

The company has received final approval from the US Food and Drug Administration (USFDA) to market Decitabine for Injection in the strength of 50 mg/vial single-dose vial.

Pfizer has said it expects to manufacture 180,000 treatment courses by the end of next month and at least 50 million courses by the end of 2022

Pfizer claims COVID-19 pill can reduce chances of death by 89%; files for FDA approval

Nov 17, 2021

Pfizer said it completed submission of its application for emergency use authorization (EUA) of the drug, Paxlovid, with the U.S. Food and Drug Administration, including data from the drugmaker's clinical trial.

Merck has given out licenses to manufacturers in developing countries to ensure a swift global supply, and companies are hopeful that Pfizer will do the same

Dr Reddy's open to making Pfizer COVID pill post deal with Merck

Nov 15, 2021

The new drugs, which unlike vaccines can be used to treat patients once they contract coronavirus infection, are expected to be a huge market.

ZyCov-D is the first Covid vaccine cleared by India's drug regulator for inoculation of those aged 12 years and above

COVID-19: Zydus Cadila's vaccine to be administered only to adults as of now, say sources

Nov 14, 2021

The health ministry has given a go ahead to initiate the preparatory work for the inclusion of the indigenously-developed, needle-free jab in the national Covid inoculation drive.

COVID vaccines have been hugely successful in preventing severe disease, but the successful deployment of these antivirals will still be significant

Merck v Pfizer: here's how the two new COVID-19 antiviral drugs work and will be used

Nov 14, 2021

That two different classes of antiviral have succeeded - one interrupting RNA replication, the other gumming up an essential protease - is tremendous news.

According to USFDA, the Mumbai-based drug maker is recalling the affected lot due to "failed moisture limits."

Sun Pharma, Lupin recall products in US market, says USFDA

Nov 07, 2021

As per the latest enforcement report by the US Food and Drug Administration (USFDA), Sun Pharma is recalling 22,752 blister packs of Loratadine-D extended-release tablets, used for the treatment of allergic rhinitis and the common cold, in the US market.

Covaxin was recently awarded Emergency Use Listing by the World Health Organization

Bharat Biotech's partner Ocugen files EUA request with FDA for paediatric use of Covaxin

Nov 05, 2021

The submission is based on results of a Phase 2/3 paediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age