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Amneal gets USFDA approval for Norelgestromin and Ethinyl Estradiol Transdermal System expresspharma
March 01, 2021
The company granted 180 days of exclusivity under FDA Competitive Generic Therapy (CGT) approval pathway.
Pfizer’s tick-borne encephalitis vaccine gets US priority review pharmatimes
February 26, 2021
The US Food and Drug Administration (FDA) has accepted for priority review Pfizer’s tick-borne encephalitis (TBE) vaccine to prevent TBE in children and adults aged one year or older.
FDA Provides Specific Compounded Drug Concerns Related to COVID-19 americanpharmaceuticalreview
February 26, 2021
The U.S. Food and Drug Administration (FDA) is advising compounders and health care providers the agency has concerns about the use of certain drugs prepared by compounders to treat patients with COVID-19.
FDA finds J&J’s single-dose Covid-19 vaccine safe and effective in trials pharmaceutical-technology
February 26, 2021
The US Food and Drug Administration (FDA) said that Johnson & Johnson’s single-shot Covid-19 vaccine, Ad26.COV2.S is safe and effective, according to the data submitted from its ongoing Phase III trials.
Zydus Cadila gets final US FDA approval for Nortriptyline Hydrochloride Capsules expresspharma
February 26, 2021
Zydus Cadila has received final approval from the USFDA to market Nortriptyline Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg and 75 mg (US RLD: Pamelor Capsules).
Gala Therapeutics Receives FDA Approval for RheOx Trial for Chronic Bronchitis americanpharmaceuticalreview
February 25, 2021
Gala Therapeutics has announced the U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to commence its pivotal clinical trial called RheSolve, which is designed to evaluate the ...
BrainStorm Receives FDA Feedback on ALS Clinical Development Program americanpharmaceuticalreview
February 25, 2021
BrainStorm Cell Therapeutics recently met with senior leadership from the U.S. Food and Drug Administration (FDA) and received FDA feedback on a high-level data summary from the NurOwn (autologous MSC-NTF cells) ALS Phase 3 clinical trial.
Intra-Cellular Therapies Applies for FDA Approval of CAPLYTA for Bipolar Depression americanpharmaceuticalreview
February 25, 2021
Intra-Cellular Therapies has recently submitted supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for two indications for CAPLYTA (lumateperone): 1) as monotherapy; and 2) as adjunctive therapy with lithium or ...
USFDA grants FTD to efanesoctocog alfa for hemophilia A treatment pharmaceutical-business-review
February 25, 2021
The U.S. Food and Drug Administration (FDA) has granted efanesoctocog alfa – earlier termed BIVV001 (rFVIIIFc-VWF-XTEN) – Fast Track Designation (FTD) for the treatment of patients suffering from hemophilia A.
Sinovac’s Covid-19 vaccine gets approval in Thailand for emergency use pharmaceutical-technology
February 25, 2021
Chinese company Sinovac Biotech has obtained approval for its Covid-19 vaccine from Thailand’s Food and Drug Administration (FDA) for local emergency use prior to the launch of a vaccination programme in the country.

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