Tag: USFDA
Walk-in Drive for Pharmacy Graduates | Ipca Laboratories | Production & Packing
Ipca Laboratories invites B.Pharm graduates for a walk-in drive in Vapi on Aug 17 for Production & Packing…
Due of the enormous increase in US FDA inspections, the pharmaceutical industry urgently has to establish a culture of quality, according to experts.
Experts have advised that it is urgently necessary to create a culture of quality in the pharmaceutical business…
Alvotech’s BLA for AVT02 receives a comprehensive response letter from the US FDA.
The US Food and Drug Administration (FDA) has responded completely to Alvotech’s Biologics Licence Application (BLA) for AVT02,…
Indian healthcare centres see relevance to USFDA Orthopaedic Non-Spinal Bone Plates, Screws and Washers guidance
Indian healthcare providers see immense relevance to US FDA Orthopaedic Non-Spinal Bone Plates, Screws and Washers Premarket Notification…
For Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, Glenmark Pharmaceuticals receives ANDA approval.
Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg, the generic version of Compazine®1 Tablets, 5 mg and…
Hutchmed has finished rolling-in its NDA for the treatment of refractory metastatic colorectal cancer to the US FDA.
Hutchmed (China) Limited reports that it has finished the rolling submission of a New Drug Application (NDA) to…
Cabaletta Bio’s IND application for CABA-201 to treat systemic lupus erythematosus has been approved by the US FDA.
The US Food and Drug Administration has approved the company’s investigational new drug (IND) application for CABA-201, a…
Abbott’s Epic Max tissue valve is approved by the US FDA to treat aortic valve disease.
In order to treat persons with aortic regurgitation or stenosis, Abbott announced that the US Food and Drug…
The OTC naloxone nasal spray from Emergent BioSolutions has received FDA approval.
The first naloxone medication to be approved for use without a prescription is Narcan, a 4 milligramme (mg)…
Ionis’ tofersen may be given accelerated approval by the USFDA for SOD1-ALS, according to the advisory committee’s unanimous vote.
Tofersen, an investigational antisense drug for the treatment of people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis,…
