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FDA Approves Gadavist® Injection americanpharmaceuticalreview
July 16, 2019
Bayer announced the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to ...
FDA approves Regeneron’s antibody Dupixent for nasal polyposis pharmaceutical-technology
June 28, 2019
The US Food and Drug Administration (FDA) has approved Dupixent, a fully-human monoclonal antibody (mAb) that is being jointly developed by Regeneron Pharmaceuticals and Sanofi under a global collaboration agreement.
FDA approves Allergan’s BOTOX for upper limb spasticity pharmaceutical-technology
June 26, 2019
The US Food and Drug Administration has approved Allergan’s supplemental biologics application (sBLA) for its BOTOX treatment for paediatric patients with upper limb spasticity.
FDA Approves KANJINTI americanpharmaceuticalreview
June 20, 2019
Amgen and Allergan announced the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product ...
FDA approves first drug for episodic cluster headaches pharmaceutical-technology
June 06, 2019
Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Emgality (galcanezumab-gnlm) for episodic cluster headache in adults.
FDA Approves First PI3K Inhibitor for Breast Cancer americanpharmaceuticalreview
May 29, 2019
The U.S. Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive ...
FDA Approves GATTEX® for Children with Short Bowel Syndrome americanpharmaceuticalreview
May 23, 2019
Takeda Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved extending the indication of GATTEX® (teduglutide) for injection to pediatric patients 1 year of age and older with ...
FDA Approves Venetoclax for CLL and SLL americanpharmaceuticalreview
May 17, 2019
The Food and Drug Administration (FDA) has approved venetoclax (VENCLEXTA, AbbVie and Genentech) for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
FDA Approves EYLEA® americanpharmaceuticalreview
May 15, 2019
Regeneron has announced the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat all stages of diabetic retinopathy (DR) which helps to reduce the risk of blindness.
FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression drugs
March 20, 2019
The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

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