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Tag: usfda

You Searched For "usfda"
SMS Lifesciences gets zero USFDA observations for Kazipally facility

SMS Lifesciences gets zero USFDA observations for Kazipally facility

Ruchika Sharma11 April 2022 11:52 AM IST
Telangana: SMS Lifesciences India has recently announced that the United States Food and Drug Administration (USFDA) has concluded an...
Indoco Remedies bags USFDA nod for Lacosamide Injection

Indoco Remedies bags USFDA nod for Lacosamide Injection

Ruchika Sharma8 April 2022 3:10 PM IST
Lacosamide injection is indicated for the prevention and control of seizures.
Health Bulletin 7/April/2022

Health Bulletin 7/April/2022

Roshni Dhar7 April 2022 5:51 PM IST
Here are the top health stories for today: Health Ministry denies detection of XE variant in India In response to the media reports that...
USFDA okays Alembic Pharma Dabigatran Etexilate Capsules

USFDA okays Alembic Pharma Dabigatran Etexilate Capsules

Ruchika Sharma7 April 2022 3:41 PM IST
Dabigatran Etexilate capsules, are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult...
Novartis gets USFDA accelerated approval for PIK3CA-Related Overgrowth Spectrum treatment Vijoice

Novartis gets USFDA accelerated approval for PIK3CA-Related Overgrowth Spectrum treatment Vijoice

Ruchika Sharma7 April 2022 11:58 AM IST
Basel: Novartis has recently announced that the U.S. Food and Drug Administration (USFDA) has granted accelerated approval to Vijoice (alpelisib) for...
Dr Reddys unveils Methylprednisolone Sodium Succinate for Injection in US

Dr Reddys unveils Methylprednisolone Sodium Succinate for Injection in US

Ruchika Sharma6 April 2022 12:23 PM IST
Methylprednisolone sodium succinate for Injection, USP is an anti-inflammatory glucocorticoid, which contains methylprednisolone sodium succinate as...
Abbott bags USFDA nod for Aveir VR leadless pacemaker to treat slow heart rhythms

Abbott bags USFDA nod for Aveir VR leadless pacemaker to treat slow heart rhythms

Ruchika Sharma6 April 2022 12:00 PM IST
The device has a unique mapping capability designed to allow physicians to measure electrical signals within the heart and determine the correct...
Lupin gets 4 USFDA observations for Tarapur facility

Lupin gets 4 USFDA observations for Tarapur facility

Ruchika Sharma6 April 2022 11:16 AM IST
Mumbai: Drugmaker, Lupin, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with four...
Sanofi Dupixent under USFDA priority review for eosinophilic esophagitis patients

Sanofi Dupixent under USFDA priority review for eosinophilic esophagitis patients

Ruchika Sharma5 April 2022 11:30 AM IST
Paris: Sanofi has recently announced that the U.S. Food and Drug Administration (USFDA) has accepted for Priority Review the supplemental Biologics...
Roche Itovebi recommended by CHMP for EU approval for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

Roche gets USFDA priority review for Actemra to treat Covid-19

Ruchika Sharma4 April 2022 2:32 PM IST
Basel: Roche today announced that the U.S. Food and Drug Administration (USFDA) has accepted the company's supplemental Biologics License Application...
Lupin gets 13 observations by USFDA for its Novel Laboratories

Lupin gets 13 observations by USFDA for its Novel Laboratories

MD Bureau1 April 2022 2:25 PM IST
Lupin Ltd on Thursday said the USFDA has issued 13 observations to its US-based wholly-owned subsidiary Novel Laboratories, Inc after an inspection.
PBT Raises Rs 18 Crore on Social Stock Exchange for Free Healthcare Initiative

Qure.ai gets Rs 300 crore from Novo Holdings and HealthQuad to expand market

MD Bureau31 March 2022 12:06 PM IST
Qure AI announced that we have secured $40 million in a funding round led by Novo Holdings and HealthQuad, supported by existing investor Mass Mutual...
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