-
Pacira BioSciences Announces FDA Acceptance of sNDA for EXPAREL Use in Pediatric Patients
americanpharmaceuticalreview
August 12, 2020
Pacira BioSciences announced the U.S. Food and Drug Administration (FDA) has accepted the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL® (bupivacaine liposome injectable suspension) label to include ...
-
FDA issues Emergency Use Authorization to Vela Diagnostics' Coronavirus PCR Test
americanpharmaceuticalreview
August 12, 2020
Vela Diagnostics announced the manual version of its coronavirus PCR test has obtained Emergency Use Authorization from the U.S. Food and Drug Administration (FDA).
-
Gilead seeks full approval for remdesivir from US FDA for COVID-19 treatment
expresspharma
August 12, 2020
To boost the drug’s availability globally, Gilead has signed multiple manufacturing and supply deals, including with Pfizer and Britain’s Hikma Pharmaceuticals.
-
Roche gets US FDA approval for Evrysdi to treat spinal muscular atrophy
expresspharma
August 12, 2020
In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of disease severity, including Types 1, 2, and 3 SMA.
-
Lupin launches Zileuton extended-release tablets
expresspharma
August 12, 2020
This tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
-
ViiV Healthcare gets FDA expanded approval for HIV-1 drug Dovato
pharmaceutical-business-review
August 11, 2020
Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Dovato (dolutegravir/lamivudine) as a complete regimen to treat HIV-1 infection.
-
FDA Approves STELARA for Pediatric Patients with Moderate to Severe Plaque Psoriasis
americanpharmaceuticalreview
August 11, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) as a treatment for pediatric patients (6-11 years of age) with the skin les
-
Neuroform Atlas Stent System Granted an Expanded Indication
americanpharmaceuticalreview
August 11, 2020
Stryker has received U.S. Food and Drug Administration (FDA) approval for an expanded indication of its Neuroform Atlas Stent System, becoming the first and only adjunctive stent approved for use in the posterior (back of the brain) circulation.
-
Genentech secures FDA approval for Evrysdi to treat SMA
pharmaceutical-technology
August 11, 2020
Roche unit Genentech has received approval from the US Food and Drug Administration (FDA) for Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in patients aged two months and above.
-
FDA Approves New Indication for Drug Containing Cannabis for Seizures in Rare Genetic Disease
americanpharmaceuticalreview
August 10, 2020
The U.S. Food and Drug Administration (FDA) has approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.