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Tag: usfda

You Searched For "usfda"
Post USFDA nod, Bluebird Bio USD 2.8 million gene therapy becomes most expensive drug

Post USFDA nod, Bluebird Bio USD 2.8 million gene therapy becomes most expensive drug

Ruchika Sharma19 Aug 2022 4:32 PM IST
Bluebird has pitched Zynteglo as a potential one-time treatment that could do away with the need for transfusions, resulting in savings for patients...
GSK Nucala application for COPD accepted for review in China

GSK new drug application for Myelofibrosis treatment Momelotinib accepted by USFDA

Ruchika Sharma19 Aug 2022 2:00 PM IST
New Delhi: GSK plc has announced that the US Food and Drug Administration (USFDA) has accepted the New Drug Application (NDA) for momelotinib, a...
Strides Pharma secures USFDA nod for pain relief drug

Strides Pharma secures USFDA nod for pain relief drug

Ruchika Sharma18 Aug 2022 5:42 PM IST
Naproxen Sodium Softgel Capsules can also be used to treat acute pain caused by other conditions.
Sun Pharma

Sun Pharma Halol facility gets OAI from USFDA

Ruchika Sharma18 Aug 2022 4:00 PM IST
New Delhi: Sun Pharmaceutical Industries Limited has announced that the Company has received a communication from the USFDA indicating the...
Lupin bags tentative USFDA nod for rare autoimmune disorder drug Amifampridine

Lupin bags USFDA okay for seizure treatment drug Rufinamide

Ruchika Sharma18 Aug 2022 3:23 PM IST
Rufinamide Tablets will be manufactured at Lupin’s facility in Goa, India.
Natco Pharma secures USFDA nod for Trabectedin for Injection

Natco Pharma secures USFDA nod for Trabectedin for Injection

Ruchika Sharma18 Aug 2022 11:23 AM IST
Hyderabad: Drugmaker, Natco Pharma Limited has recently announced that the U.S. Food and Drug Administration (USFDA) has granted tentative approval...
USFDA approves sale of OTC hearing aids

USFDA approves sale of OTC hearing aids

Ruchika Sharma17 Aug 2022 1:00 PM IST
The aids will be available directly from stores or online without medical exams, a prescription or audiologist fitting adjustment.
Unichem Labs bags USFDA nod for Bipolar disorder drug

Unichem Labs bags USFDA nod for Bipolar disorder drug

Ruchika Sharma16 Aug 2022 5:00 PM IST
New Delhi: Unichem Laboratories Limited today announced that the company has received Abbreviated New Drug Application (ANDA) approval for its...
USFDA nod to Aurobindo Pharma arms Vasopressin Injection

USFDA nod to Aurobindo Pharma arm's Vasopressin Injection

Ruchika Sharma16 Aug 2022 3:58 PM IST
Hyderabad: Drugmaker, Aurobindo Pharma Limited, today announced that its wholly owned subsidiary company, Eugia Pharma Specialties Limited, has...
Sun Pharma

Sun Pharma gets 6 USFDA observations for Mohali facility

Ruchika Sharma16 Aug 2022 12:30 PM IST
New Delhi: Drugmaker, Sun Pharmaceutical Industries Limited, has recently announced that the US Food and Drug Administration (USFDA) has...
Sun Pharma, Dr Reddys Labs and 2 others recall products in US

Sun Pharma, Dr Reddy's Labs and 2 others recall products in US

Ruchika Sharma16 Aug 2022 11:38 AM IST
As per the USFDA, Sun Pharma is recalling 9,552 bottles of epilepsy treatment drug Divalproex Sodium delayed-release tablets due to "Failed...
Roche Itovebi recommended by CHMP for EU approval for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

Roche Xofluza bags USFDA okay for influenza treatment in children aged five years and older

Ruchika Sharma15 Aug 2022 4:00 PM IST
Xofluza is available as a one-dose, single-tablet
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