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FDA Recommends Discussing Naloxone When Prescribing Opioids, Opioid Use Disorder Treatments
americanpharmaceuticalreview
July 28, 2020
To reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (FDA) is making the following recommendations about the opioid reversal medicine, naloxone.
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FDA Clears Abivertinib for Safety, Efficacy Study in COVID-19 Hospitalized Patients
americanpharmaceuticalreview
July 28, 2020
Sorrento Therapeutics received clearance from the FDA to initiate a Phase 2 trial of Abivertinib in patients with COVID-19 who have moderate to severe pulmonary symptoms.
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DRL receives US FDA’s approval for XEGLYZETM (abametapir) lotion
expresspharma
July 28, 2020
XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
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FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing
americanpharmaceuticalreview
July 27, 2020
The U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under ...
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FDA orders update of label change for opioid pain medications
europeanpharmaceuticalreview
July 27, 2020
The FDA is requiring that labels for opioid pain medicine and medicines to treat opioid use disorder recommend healthcare professionals discuss the availability of naloxone with patients to reduce overdoses.
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FDA approves Tecartus, cell-based gene therapy to treat relapsed or refractory MCL in adults
expresspharma
July 27, 2020
It also received ‘Orphan Drug’ designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
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Lupin, Granules India recall around 9.71 lakh bottles of diabetes drug in the US
expresspharma
July 27, 2020
Various companies across the globe have announced similar recalls for the product after the USFDA pointed out the presence of NDMA above permissible limits.
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Oramed Reports Positive End of Phase 2 Meeting with the FDA for Oral Insulin
americanpharmaceuticalreview
July 24, 2020
Oramed Pharmaceuticals announced the FDA provided positive feedback during the company's End of Phase 2 (EOP2) meeting for Oramed's oral insulin (ORMD-0801).
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Maha FDA files FIR against five people, guilty in blackmarketing of remedisivir and tocilizumab
expresspharma
July 24, 2020
The team seized medicines worth Rs 3,13,482 for COVID-19 and other therapeutic categories.
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Zydus Cadila gets US FDA nod for drug trials to treat chemotherapy-induced anemia
expresspharma
July 24, 2020
Desidustat is a novel drug which is also currently undergoing phase-III trials for treating anemia in chronic kidney disease patients and phase-II studies for management of COVID-19 patients.