USFDA approves Biocon’s sBLA for Pegfilgrastim new manufacturing facility
Expanded capacity will enable greater patient access globally
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USFDA
FDA puts in efforts to help make development of biosimilar and interchangeable insulin products
Consistent, life-long access to insulin is imperative to patient survival and quality of life, says American pediatrician Adm…
FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection
The Tubes Under Local Anesthesia (Tula) system is the first ear tube delivery system that can be performed in young children using…
Takeda expands India portfolio of rare disease therapies
Company launches enzyme replacement therapy bouquet for Lysosomal Storage Disorders (LSD), Idursulfase for Hunter Syndrome,…
Strides announces relaunch of ranitidine tablets for the US Market
Product to be relaunched with immediate effect
Jubilant Cadista Inc recalls 63,216 bottles of erosive esophagitis tablets
Jubilant Generics at its Roorkee plant, the Enforcement Report of the US Food and Drug Adminstration (USFDA) said
Macleods Pharma USA Inc recalls 31,968 bottles of diabetes drug in US
The tablets being recalled are in the strength of 15 mg and have been manufactured by Macleods Pharmaceuticals in its Baddi…
Dr Reddy’s gets four observations from USFDA for Srikakulam plant
The audit of the company's API Srikakulam Plant (SEZ) was completed last week
Aurobindo Pharma gets USFDA nod for its expectorant tablets
The tablets are the generic version of RB Health (US) LLC's Mucinex tablet, the company said
Dr Reddy’s recalls all its ranitidine products in US
The recall started on October 1 after USFDA found the presence of NDMA in certain ranitidine products above the permissable levels…