US FOOD AND DRUG ADMINISTRATION
Rhizen receives USFDA orphan drug designation for cancer drugThe US Food and Drug Administration (USFDA) has granted orphan drug designation for Tenalisib (RP6530) for the treatment of patients with p...
- India's Bharat Biotech seeks emergency use approval for vaccine in Philippines
Bharat Biotech, which has developed COVAXIN with the Indian Council of Medical Research, is the fourth vaccine maker to apply for emergency...
- Ascend Laboratories recalls over 20,000 bottles of antibacterial drug in US
The US-based Ascend Laboratories LLC is recalling 20,232 bottles of Cephalexin for oral suspension, USP, 125 mg per 5 mL, manufactured by A...
- Strides Pharma Science arm gets USFDA nod for HIV treatment drug
Drug firm Strides Pharma Science on Friday said its step-down wholly-owned subsidiary, Strides Pharma Global, has received approval from th...
- Johnson & Johnson’s one-dose vaccine elicits ‘strong immune response’
Neutralising antibodies formed in more than 90% of the participants by day 29 and in 100% of the participants aged 18-55 years on day 57.
- Unichem Labs gets American drug regulator's nod to market generic Celecoxib capsules
The company has received abbreviated new drug application (ANDA) approval for its Celecoxib capsules in the strengths of 50 mg, 100 mg, 200...
- Granules gets American drug regulator's nod for diabetes management drug Metformin
The US Food and Drug Administration (USFDA) has granted final approval for the company's abbreviated new drug application (ANDA) for Metfor...
- Dr Reddy's launches generic drug in the US market
The company has launched the product, which is a generic version of Teijin Ltd's Uloric tablets, after getting approval from the US Food an...
- Cipla recalls over 5.8 lakh packets of gastric ulcer treatment drug in US
The drug major is recalling esomeprazole magnesium for delayed-release oral suspension in unit dose packets in strengths 10 mg, 20 mg and 4...
- White House task force warns of new 'USA variant' of Covid-19
This comes after a new variant said to be 70 per cent more transmissible was reported in the United Kingdom last year.
- JB Chemicals gets USFDA nod for generic product
The US Food and Drug Administration (USFDA) has approved company's abbreviated new drug application (ANDA) for Loratadine tablets USP 10 mg...
- Lupin gets USFDA nod for generic diabetes drug
The company has received tentative approval for the product in multiple strengths from the United States Food and Drug Administration (USFD...
- Lupin launches generic drug in the US market
The Mumbai-based drug firm's product is the generic equivalent of Zyla Life Sciences' Vivlodex Capsules (5 mg and 10 mg). The capsules are ...
- Avenue Therapeutics gets regulatory update for intravenous tramadol, says Cipla
In October this year, Avenue Therapeutics Inc had received a complete response letter (CRL) from the USFDA which stated that the regulator ...
- Single Covid-19 vaccine dose or double? Data put regulators in a fix
The US Food and Drug Administration has released its findings on the Pfizer/BioNtech efficacy data where it suggested that the vaccine at a...
- Zydus Cadila gets USFDA Fast Track Designation for Saroglitazar
Drug firm Zydus Cadila on Wednesday said it has received Fast Track Designation from the US health regulator for its investigational drug c...
- Aurobindo Pharma gets USFDA nod for sedative drug
Drug major Aurobindo Pharma On Wednesday said it has received final approval from the US health regulator for generic of Precedex injection...
- BioNTech, Pfizer ask Europe to quickly approve virus vaccine
The German pharmaceutical company BioNTech and its U.S. partner Pfizer say they have submitted an application for speeded-up, conditional a...
- Strides Pharma Science gets USFDA nod for Prednisone tablets
Strides Pharma Science Ltd on Monday said it has received approval from the US health regulator for its generic version of Prednisone table...
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