Ipsen
FDA Approves IQIRVO — Ipsen Biopharmaceuticals, Inc.
Ipsen Biopharmaceuticals announced on Thursday the U.S. FDA approval of IQIRVO (elafibranor), marking the entry of the first non-bile acid derivative ...
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Geron
FDA Approves RYTELO — Geron Corporation
# FDA Approves Geron Corporation's RYTELO (imetelstat sodium) for Telomerase-Targeted Therapy Geron Corporation received FDA approval for RYTELO (ime...
Advagen
FDA Approves CARBIDOPA AND LEVODOPA — Advagen Pharma Ltd
# FDA Approves Generic Carbidopa and Levodopa from Advagen Pharma Advagen Pharma Ltd has received FDA approval for its generic formulation of carbido...
IPCA
FDA Approves Unknown Drug — IPCA LABS LTD
# FDA Approves IPCA Laboratories' Generic Drug Application IPCA Laboratories Limited received FDA approval for an abbreviated new drug application (A...
Elite
FDA Approves METHOTREXATE SODIUM — Elite Laboratories, Inc.
# FDA Approves Elite Laboratories' Generic Methotrexate Sodium Oral Formulation Elite Laboratories, Inc. has received FDA approval for its generic me...
Dr.
FDA Approves VASOPRESSIN — Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Laboratories received FDA approval for its intravenous vasopressin generic, positioning the company to immediately capture market share in...
Neurocrine
FDA Approves INGREZZA SPRINKLE — Neurocrine Biosciences, Inc.
# FDA Approves Neurocrine Biosciences' INGREZZA SPRINKLE for Tardive Dyskinesia Treatment Neurocrine Biosciences, Inc. has received FDA approval for ...
AbbVie
FDA Approves RINVOQ — AbbVie Inc.
Attribution of this breakthrough can be reserved for the **AbbVie** approval of the oral rheumatoid arthritis therapy RINVOQ (upadacitinib). The nod r...
Scienture
FDA Approves REZENOPY — Scienture LLC
Scienture LLC announced FDA approval for REZENOPY, a generic naloxone hydrochloride nasal spray, marking the company’s entry into the rapid-growth mar...
La
FDA Approves ZEVTERA — La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company secured FDA approval for ZEVTERA (ceftobiprole medocaril sodium), positioning itself in the IV antibiotic market to ad...
Akebia
FDA Approves VAFSEO — Akebia Therapeutics, Inc.
# FDA Approves Akebia Therapeutics' VAFSEO for Anemia Treatment The FDA has approved Akebia Therapeutics' VAFSEO (vadadustat), an oral hypoxia-induci...
Merck
FDA Approves WINREVAIR — Merck Sharp & Dohme LLC
# FDA Approves Merck's WINREVAIR (sotatercept-csrk), Expanding Treatment Options in Pulmonary Hypertension Market Merck Sharp & Dohme LLC's FDA appro...
Advagen
FDA Approves OXCARBAZEPINE — Advagen Pharma Ltd.
Advagen Pharma Ltd. announced the March 5 FDA approval of its ANDA207717 for the oral formulation of oxycarbazepine, providing clearance to market the...
BluePoint
FDA Approves CAPECITABINE — BluePoint Laboratories
BluePoint Laboratories has received marketing authorization from the FDA for its generic version of CAPECITABINE, positioning the firm to capturemarke...
Fresenius
FDA Approves TYENNE — Fresenius Kabi USA, LLC
Fresenius Kabi USA has announced FDA approval of tocilizumab (Tyenne, BLA761275) for the treatment of moderate to severe active rheumatoid arthritis, ...
Padagis
FDA Approves LENALIDOMIDE — Padagis US LLC
Padagis US LLC announced the FDA approval of its oral lenalidomide ANDA, positioning the company to compete in the generic oncology market where an in...
Kanchan
FDA Approves OXCARBAZEPINE — Kanchan Healthcare Inc
Kanchan Healthcare Inc. has achieved FDA approval for its ANDA-217782, launching the generic version of oxcarbazepine oral tablets. The move positions...
Aurobindo
FDA Approves ISOTRETINOIN — Aurobindo Pharma Limited
# FDA Approves Generic Isotretinoin ANDA from Aurobindo Pharma Aurobindo Pharma Limited received FDA approval for its generic isotretinoin oral formu...
Aurobindo
FDA Approves LACOSAMIDE — Aurobindo Pharma Limited
# FDA Approves Generic Lacosamide from Aurobindo Pharma The U.S. Food and Drug Administration has approved Aurobindo Pharma Limited's generic lacosam...
Lifestar
FDA Approves ATROPINE SULFATE — Lifestar Pharma LLC
The FDA has granted approval to Lifestar Pharma LLC’s ANDA for Atropine Sulfate Ophthalmic Solution, a generic alternative to branded versions used fo...