World's first RSV vaccine: GSK wins USFDA nod for Arexvy in older adults Ruchika Sharma4 May 2023 11:48 AM ISTRespiratory syncytial virus is a common contagious virus affecting the lungs and breathing passages.
USFDA nod to physiotherapy monitoring device Pheezee Ruchika Sharma3 May 2023 4:30 PM ISTThe device generates reports, for the first time in the field of physiotherapy, enabling patients to track their recovery.
USFDA issues EIR for Indoco Remedies Goa facility Ruchika Sharma3 May 2023 3:55 PM ISTMumbai: Indoco Remedies Ltd. announced today the receipt of an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status...
Boehringer Ingelheim Spesolimab bags USFDA Breakthrough Therapy Designation for prevention of generalized pustular psoriasis flares Ruchika Sharma3 May 2023 2:30 PM ISTGeneralized pustular psoriasis is a rare and potentially life-threatening chronic neutrophilic skin disease characterized by flares of widespread...
Cipla arm gets zero Form 483 observations from USFDA for USA facility Ruchika Sharma3 May 2023 12:30 PM ISTMumbai: Cipla has recently announced that the US Food and Drug Administration has concluded inspection with zero Form 483 observations at the Fall...
Laurus Labs bags USFDA nod for Paediatric ARV Oral Dispersible Film drug Dolutegravir in HIV/AIDS treatment Ruchika Sharma2 May 2023 4:24 PM ISTHyderabad: Laurus Labs Ltd., a R&D driven pharmaceutical & biotech manufacturing company in India, has announced the receipt of the US Food...
USFDA halts Sun Pharma trials on dermatological drug Deuruxolitinib Ruchika Sharma2 May 2023 2:46 PM ISTThe company said it would work closely with the FDA to address the agency's concerns, which the drugmaker expected to be communicated within the next...
Bristol Myers Squibb gets USFDA priority review for expanded Reblozyl use Ruchika Sharma1 May 2023 5:31 PM ISTReblozyl, a first-in-class therapeutic option, promotes late-stage red blood cell maturation in animal models.
USFDA panel backs restricted use of AstraZeneca Prostrate cancer drug Ruchika Sharma29 April 2023 12:30 PM ISTLynparza belongs to a class of drugs called PARP inhibitors, which include Clovis Oncology's Rubraca and GSK Plc's Zejula.
Pfizer gets USFDA approval for 20-valent Pneumococcal Conjugate Vaccine PREVNAR 20 for infants, children Ruchika Sharma28 April 2023 11:43 AM ISTPREVNAR 20 builds on Pfizer's approved PREVNAR 13 vaccine, and includes seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) shown to be...
Ipca Labs gets 3 USFDA observations for Piparia facility Ruchika Sharma27 April 2023 11:15 AM ISTMumbai: Ipca Laboratories has recently announced that the US Food and Drug Administration (USFDA) has issued a Form 483 with 3 observations at the...
Zydus Lifesciences bags USFDA nod for Metronidazole topical cream to treat skin disorder Ruchika Sharma25 April 2023 5:15 PM ISTThe drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad, India.
