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Results For "US-FDA"

251 News Found

Medtech player Healthium acquires CareNow
Packaging | September 02, 2021

Medtech player Healthium acquires CareNow

This is the third acquisition by Healthium this year apart from AbGel business in India and VitalCare in the UK


Morpen Laboratories to transfer its medical devices business to a wholly owned subsidiary
News | September 02, 2021

Morpen Laboratories to transfer its medical devices business to a wholly owned subsidiary

The revenues and profits derived from the new subsidiary will be consolidated in the parent company


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke


Roche withdraws the US accelerated approval for Tecentriq
Drug Approval | August 28, 2021

Roche withdraws the US accelerated approval for Tecentriq

Roche is notifying healthcare professionals and patients in the US about this withdrawal. Patients being treated with Tecentriq for PD-L1-positive mTNBC should discuss their care with their healthcare provider


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Johnson & Johnson booster dose indicate impressive results
Drug Approval | August 26, 2021

Johnson & Johnson booster dose indicate impressive results

New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson Covid-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination.


Caplin Point Lab's subsidiary receives nod from Brazil's ANVISA for sterile injectable manufacturing site
Drug Approval | August 17, 2021

Caplin Point Lab's subsidiary receives nod from Brazil's ANVISA for sterile injectable manufacturing site

The approval allows it to market its products in the country


Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%
Drug Approval | August 12, 2021

Cipla receives USFDA approval for Difluprednate Ophthalmic Emulsion 0.05%

It’s an AB-rated generic therapeutic version of Durezol


Alkem launches Ibuprofen and Famotidine tablets in US
News | August 07, 2021

Alkem launches Ibuprofen and Famotidine tablets in US

Ibuprofen and Famotidine Tablets is an AB-rated generic therapeutic equivalent version of Horizon Medicines LLC’s Duexis Tablets, 800 mg/26.6 mg


Alkem launch two drugs in US
News | August 04, 2021

Alkem launch two drugs in US

Ibuprofen and Famotidine tablets approved by FDA