Sun Pharma recalls over 24000 prefilled syringes of infertility drug in US
The company is recalling the affected lot due to the presence of particulate matter
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US FDA
US FDA approves GSK’s Arexvy, world’s first RSV vaccine for older adults
Older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at…
US FDA asks Sun Pharma to stop trial on dermatological drug citing potential of blood clots
Sun Pharma acquired deuruxolitinib when it bought Concert Pharmaceuticals for $576 million earlier this year
GSK launches shingles vaccine, Shingrix in India
Shingrix is a non-live, recombinant subunit vaccine to be given intramuscularly in two doses for the prevention of shingles…
US FDA withdraws approval for Makena, Covis Pharma’s preterm birth prevention drug
The US FDA has been pushing to withdraw the drug since 2020 but Covis insisted that the FDA wait for data from another…
Granules India gets ANDA approval for Gabapentin tablets
Gabapentin tablets are indicated for management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment…
Lupin gets tentative US FDA approval for Valbenazine capsules
Valbenazine is indicated for the treatment of tardive dyskinesia (uncontrollable movement of face, tongue, or other body parts)
US FDA accepts Glenmark’s IND application for GRC 54276 to proceed with Phase 1/2 clinical study for…
GRC54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark
Glenmark gets ANDA approval for Clindamycin Hydrochloride Capsules
Glenmark Pharmaceuticals has received final approval from the United States Food & Drug Administration (US FDA) for…
Cingulate and Indegene sign agreement for lead ADHD candidate CTx-1301
The agreement spans cross-functional services through an omnichannel marketing approach designed to manage pre-commercial support…