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Tag: usfda

You Searched For "usfda"
Lack of full disclosure: SEBI issues warning letter to Aurobindo Pharma

Lack of full disclosure: SEBI issues warning letter to Aurobindo Pharma

Rahul Verma30 Jun 2022 6:15 PM IST
Aurobindo Pharma Ltd on Monday said it has received a warning letter from capital markets regulator Sebi for non-disclosure of details related to an...
Janssen Pharma gets USFDA Breakthrough Therapy Designation for Multiple Myeloma treatment Talquetamab

Janssen Pharma gets USFDA Breakthrough Therapy Designation for Multiple Myeloma treatment Talquetamab

Ruchika Sharma30 Jun 2022 3:02 PM IST
Talquetamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting both GPRC5D, a novel drug target, on multiple...
GE Healthcare ventilator batteries recall classified most serious by USFDA

GE Healthcare ventilator batteries recall classified most serious by USFDA

Ruchika Sharma29 Jun 2022 2:00 PM IST
GE Healthcare, the medical device making arm of General Electric, had initiated the recall of 4,222 of its ventilator batteries distributed between...
Spero Therapeutics urinary tract infection drug Tebipenem rejected by USFDA

Spero Therapeutics urinary tract infection drug Tebipenem rejected by USFDA

Ruchika Sharma28 Jun 2022 2:56 PM IST
The drugmaker said on Monday it intends to promptly request a meeting with the health regulator.
Lack of full disclosure: SEBI slaps warning letter on Aurobindo Pharma

Lack of full disclosure: SEBI slaps warning letter on Aurobindo Pharma

Ruchika Sharma28 Jun 2022 11:00 AM IST
"Any such aberration in future would be viewed seriously and appropriate action would be initiated," Sebi said.
Bristol Myers Squibb bags USFDA nod for CAR T Cell Therapy Breyanzi

Bristol Myers Squibb bags USFDA nod for CAR T Cell Therapy Breyanzi

Ruchika Sharma26 Jun 2022 4:00 PM IST
Breyanzi, a differentiated CAR T cell therapy, is made from a patient's own T cells, which are collected and genetically reengineered to become CAR T...
Pfizer sued for patent infringement over Paxlovid

Pfizer sued for patent infringement over Paxlovid

Roshni Dhar25 Jun 2022 5:30 PM IST
Pfizer Inc's blockbuster COVID-19 treatment Paxlovid violates an Enanta Pharmaceuticals Inc patent for its COVID drug still in development, according...
Glenmark receives 6 USFDA observations for Baddi facility

Glenmark receives 6 USFDA observations for Baddi facility

Roshni Dhar24 Jun 2022 6:00 PM IST
Drugmaker, Glenmark Pharmaceuticals Ltd, has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with six...
Health Bulletin 24/June/2022

Health Bulletin 24/June/2022

Roshni Dhar24 Jun 2022 5:20 PM IST
Here are the top health stories for the day:NEET 2022 not postponed Breaking the hearts of all the NEET UG 2022 aspirants, who have...
Baxter International lung therapy devices recall classified most serious by USFDA

Baxter International lung therapy devices recall classified most serious by USFDA

Ruchika Sharma24 Jun 2022 2:30 PM IST
The FDA said the adaptor may prevent patients from getting enough oxygen from their ventilators, and possibly lead to death if caregivers are not...
USFDA nod to Novartis Tafinlar plus Mekinist for solid tumors with gene mutation

USFDA nod to Novartis Tafinlar plus Mekinist for solid tumors with gene mutation

Ruchika Sharma23 Jun 2022 2:47 PM IST
BRAF V600E is the most common type of BRAF mutation, accounting for up to 90% of BRAF-mutant cancers.
Merck Pneumococcal 15-valent Conjugate Vaccine gets USFDA nod for pediatric use

Merck Pneumococcal 15-valent Conjugate Vaccine gets USFDA nod for pediatric use

Ruchika Sharma23 Jun 2022 12:45 PM IST
Rahway: Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (USFDA) has approved an...
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