Tag: FDA Approved

Sage’s Zulresso Gets Final US Clearance

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Sage Therapeutics has gained clearance from the US Drug Enforcement Administration (DEA) to make its postpartum depression treatment Zulresso available to the first patients. The drug gained approv...

Amgen and Allergan’s Biosimilar To Herceptin Approved by FDA

Amgen and Allergan plc announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzum...

Two New Indications for Merck’s KEYTRUDA Approved by FDA

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients whose ...

PTC Therapeutics Announced FDA Approval for Emflaza

PTC Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Emflaza® (deflazacort) to expand its labeling to i...

FDA Approved NDA for Oral Contraceptive Tablet for Pregnancy Prevention

Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Slynd™ (pronounce...

First Device for Reduction of Functional Abdominal Pain in Patients 11-18 years Permitted by FDA

The U.S. Food and Drug Administration permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome ...

FDA Approved Eli Lilly’s Emgality

The U.S. Food and Drug Administration approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults.  “Emgality provides patients with the firs...

FDA Approves New Treatment for HABP/VABP

The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumo...

FDA Approves sNDA for XOSPATA®

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XOSPATA® (gilteritinib) to i...

FDA Approval for Bipolar Depression Treatment Granted to Allergan

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Allergan plc and Gedeon Richter Plc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine) for expanded use to t...

Celgene Received FDA Approval for REVLIMID

Celgene Corporation announced the U.S. Food and Drug Administration (FDA) approved REVLIMID® (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previo...

FDA Approved Incyte’s treatment for Graft vs Host Disease

The U.S. Food and Drug Administration on Friday approved Incyte Corp’s treatment for acute Graft versus Host disease (GvHD), an inflammatory response by the immune system after a bone marrow transplan...

Glenmark Received Final Approval from FDA for Aspirin

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Aspirin and Extended-Release Dipyridamole Capsules, 25 ...

Novartis’ Piqray Granted Approval by FDA

The U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with h...

FDA Approved First Gene Therapy to Treat Children with SMA

The U.S. Food and Drug Administration approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA...

FDA Granted Marketing Permission for Prosthetic Joint Infections Test

The U.S. Food and Drug Administration permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for the detection of periprosthetic joint infection (infection around a joint replacement) i...