Shilpa Medicare gets USFDA nod for Tenofovir Alafenamide Tablets Ruchika Sharma19 Sept 2022 11:25 AM ISTNew Delhi: Shilpa Medicare has recently announced that the Company has received U.S Food and Drug Administration (USFDA) tentative approval for...
USFDA issues 2 observations for Alkem Labs St Louis facility Ruchika Sharma17 Sept 2022 10:30 AM ISTMaharashtra: Alkem Labs has recently announced that the US Food and Drug Administration (USFDA) has issued two observations after a pre-approval...
Gilead Sciences settles patent disputes with Lupin, Cipla and 3 others over HIV, Hepatitis B drugs generic versions Ruchika Sharma16 Sept 2022 5:28 PM ISTThe generic drugmakers argued that the patents were invalid and unenforceable. They said in an August court filing that Gilead's patents covered...
Zydus Lifesciences US arm secures USFDA nod for Sugammadex Injection Ruchika Sharma16 Sept 2022 1:30 PM ISTThe drug will be manufactured at the group’s injectables manufacturing facility at Jarod, India.
Ajanta Pharma Dahej facility gets 2 procedural observations from USFDA Ruchika Sharma13 Sept 2022 12:15 PM ISTThe formulation facility was inspected by USFDA from 5th September 2022 to 9th September 2022.
Zydus Lifesciences US arm bags USFDA nod for schizophrenia drug Cariprazine Ruchika Sharma13 Sept 2022 11:01 AM ISTCariprazine is an atypical antipsychotic indicated for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with...
Bristol Myers Squibb bags USFDA approval for plaque psoriasis oral treatment Sotyktu Ruchika Sharma12 Sept 2022 1:29 PM ISTPsoriasis is a widely prevalent, chronic, systemic immune-mediated disease.
USFDA accepts regulatory submission for Pfizer alopecia areata treatment Ritlecitinib Ruchika Sharma10 Sept 2022 5:15 PM ISTAlopecia areata is an autoimmune disease that has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the...
Heart valve repair device: USFDA warns of potential clip lock issue with Abbott Labs MitraClip Ruchika Sharma9 Sept 2022 3:30 PM ISTAbbott said it had received increased rate of reports of the devices failing to "establish final arm angle" or "clip opening while locked".
Lupin unveils Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution in US Ruchika Sharma9 Sept 2022 12:27 PM ISTThe product is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
Novo Nordisk, Zealand Pharma collaborate for ZEGALOGUE for injection Ruchika Sharma9 Sept 2022 11:33 AM ISTUnder the terms of the agreement, Zealand will receive an upfront payment of DKK 25 million and is eligible to receive up to DKK 45 million in...
Panacea Biotec arm gets USFDA OAI status for Baddi facility Ruchika Sharma8 Sept 2022 4:52 PM IST"PBPL is working closely with USFDA to close these observations and the closure of the warning letter issued by the USFDA earlier on September 24,...
