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FDA Grants ODD for Esophageal, Gastroesophageal Junction, Pancreatic Cancer Treatment americanpharmaceuticalreview
October 21, 2020
Apexigen announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation status to APX005M for the treatment of esophageal and gastroesophageal junction cancer and for the treatment of pancreatic cancer.
Harmony Biosciences Receives FDA Approval for Expanded Use of WAKIX americanpharmaceuticalreview
October 21, 2020
Harmony Biosciences announced the U.S. Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy.
The FDA requires changes to NSAID labelling europeanpharmaceuticalreview
October 21, 2020
The FDA is requiring that the prescribing information for nonsteroidal anti-inflammatory drugs (NSAIDs) include warnings about potential foetal kidney problems if taken by women over 20 weeks pregnant.
Y-mAbs announces FDA clearance of IND for its Lutetium-177 labelled omburtamab antibody pharmaceutical-business-review
October 21, 2020
Y-mAbs Therapeutics announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer..
Pfizer to seek approval for Covid-19 vaccine candidate next month pharmaceutical-technology
October 19, 2020
Pfizer has announced plans to submit an application to the US Food and Drug Administration (FDA) seeking approval for its Covid-19 vaccine candidate next month.
Zydus Cadila gets US FDA approval for fingolimod capsules and verapamil hydrochloride injection expresspharma
October 19, 2020
Fingolimod is an immunomodulating drug to treat multiple sclerosis and Verapamil injection is restore normal heartbeats in people with certain heart rhythm disorders.
US FDA approves Amantadine Hydrochloride Tablets, 100 mg from Alembic Pharma expresspharma
October 19, 2020
They are indicated for prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus as well as treatment of Parkinsonism and drug-induced extrapyramidal reactions.
Genentech announces full FDA approval for Venclexta combinations for acute myeloid leukaemia expresspharma
October 19, 2020
Genentech, a member of the Roche Group, announced that the US Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment ...
Zydus Cadila gets final nod for Ursodiol capsules, tentative nod for Linagliptin and Metformin Hydrochloride tablets expresspharma
October 19, 2020
Zydus Cadila has received final approval from the USFDA to market Ursodiol Capsules USP, 300 mg (US RLD: Actigall Capsules).
Avenue Therapeutics Receives Complete Response Letter from FDA for IV Tramadol americanpharmaceuticalreview
October 16, 2020
Avenue Therapeutics has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for IV tramadol.

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