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FDA approves Keytruda plus Lenvima for advanced kidney cancer pharmatimes
August 13, 2021
The US Food and Drug Administration (FDA) has approved a combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) for the first-line treatment of adult patients with advanced renal cell carcinoma ...
FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment fda.gov
August 13, 2021
The U.S. Food and Drug Administration today approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's sleep.
FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease drugs
August 12, 2021
FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD).
Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Rolontis (eflapegrastim) drugs
August 10, 2021
Spectrum Pharmaceuticals today announced receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for Rolontis® (eflapegrastim).
US FDA approves Nexviazyme for late-onset Pompe disease expresspharma
August 09, 2021
The approval is based on the positive phase-III data demonstrating improvements in key disease burden measures and establishing its safety profile.
FDA Approves Nexviazyme (avalglucosidase alfa-ngpt) for Late-Onset Pompe Disease drugs
August 09, 2021
The U.S. Food and Drug Administration (FDA) has approved Nexviazyme (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilitating muscle disorder.
FDA to allow export of certain lots of AstraZeneca COVID-19 vaccine made at Baltimore plant firstwordpharma
August 09, 2021
The FDA said certain lots of AstraZeneca's COVID-19 vaccine manufactured at Emergent Biosolutions' Baltimore facility are fit to be shipped outside the US, as reported Financial Post.
FDA Fast Track designation given to mRNA RSV vaccine europeanpharmaceuticalreview
August 06, 2021
Moderna’s mRNA respiratory syncytial virus (RSV) vaccine candidate, mRNA-1345, gains Fast Track designation in adults over 60 years old.
Alembic Pharmaceuticals gets USFDA approval for Clomipramine Hydrochloride Capsules expresspharma
August 06, 2021
The capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD).
FDA Accepts Application for Genentech’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) firstwordpharma
August 06, 2021
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment.

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