Gilead
FDA Approves SUNLENCA — Gilead Sciences, Inc.
# FDA Approves Gilead Sciences' SUNLENCA (lenacapavir sodium), a First-in-Class HIV Treatment Gilead Sciences, Inc. received FDA approval for SUNLENC...
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Gilead
FDA Approves SUNLENCA — Gilead Sciences, Inc.
# FDA Approves Gilead Sciences' SUNLENCA (Lenacapavir Sodium) for HIV Treatment Gilead Sciences, Inc. received FDA approval for SUNLENCA (lenacapavir...
Apotex
FDA Approves BRIMONIDINE TARTRATE — Apotex Corp.
# FDA Approves Generic Brimonidine Tartrate from Apotex Corp. The FDA has approved Apotex Corp.'s abbreviated new drug application for generic brimon...
NorthStar
FDA Approves LEVOTHYROXINE SODIUM — NorthStar RxLLC
# FDA Approves NorthStar RxLLC's Generic Levothyroxine Sodium The U.S. Food and Drug Administration has approved NorthStar RxLLC's abbreviated new dr...
Cycle
FDA Approves TASCENSO ODT — Cycle Pharmaceuticals Ltd
Cycle Pharmaceuticals Ltd announced the FDA approval of TASCENSO ODT (fingolimod lauryl sulfate), its new once-daily oral formulation for demyelinatin...
EPIC
FDA Approves OXCARBAZEPINE — EPIC PHARMA, LLC
On November 30, 2022, **Epic Pharma, LLC** announced the approval of its Abbreviated New Drug Application (ANDA) 215332 for OXCARBAZEPINE, ensuring co...
Aurobindo
FDA Approves CARBIDOPA AND LEVODOPA — Aurobindo Pharma Limited
Aurobindo Pharma Limited secured FDA approval for its generic Carbidopa and Levodopa oral tablet, positioning the company to capitalize on cost-sensit...
Provention
FDA Approves TZIELD — Provention Bio, Inc.
The FDA granted accelerated approval to Provention Bio’s TEPLIZUMAB-MZWV (TZIELD), a novel immunotherapy for type 1 diabetes, significantly bolstering...
Amneal
FDA Approves LEUPROLIDE ACETATE — Amneal Pharmaceuticals LLC
# FDA Approves Generic Leuprolide Acetate for Amneal Pharmaceuticals Amneal Pharmaceuticals LLC received FDA approval for its generic leuprolide acet...
Janssen
FDA Approves TECVAYLI — Janssen Biotech, Inc.
# FDA Approves Janssen Biotech's TECVAYLI for Multiple Myeloma Treatment The FDA has approved Janssen Biotech's TECVAYLI (teclistamab-cqyv), a subcut...
Advagen
FDA Approves CARBIDOPA-LEVODOPA — Advagen Pharma Ltd.,
**CARBIDOPA AND LEVODOPA** tablets have received FDA approval through the **Advagen Pharma Ltd.** ANDA, a move expected to intensify price competition...
Mallinckrodt
FDA Approves TERLIVAZ — Mallinckrodt Hospital Products Inc.
Mallinckrodt Hospital Products Inc. announced FDA approval of the intravenous drug TERLIPRESSIN (Generic: TERLIPRESSIN), a significant milestone for t...
Zydus
FDA Approves LENALIDOMIDE — Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc. announced on Tuesday the FDA approval of a generic version of global immunomodulatory drug manufacturer Johnson & Johns...
E.R.
FDA Approves SOTYKTU — E.R. Squibb & Sons, L.L.C.
The FDA has granted approval to Squibb’s oral drug SOTYKTU (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis, a development t...
Novadoz
FDA Approves VIGABATRIN — Novadoz Pharmaceuticals LLC
Novadoz Pharmaceuticals LLC has secured FDA approval for its generic Vigabatrin oral formulation, positioning the company to capitalize on cost-saving...
EXELAN
FDA Approves LENALIDOMIDE — EXELAN PHARMACEUTICALS INC.
# FDA Approves Generic LENALIDOMIDE; Exelan Pharmaceuticals Enters High-Value Oncology Market Exelan Pharmaceuticals Inc. received FDA approval for i...
MSN
FDA Approves Unknown Drug — MSN
# FDA Approves ANDA for MSN The FDA has approved ANDA 211135 for MSN as of September 1, 2022, potentially expanding the company's portfolio in the ge...
Alvogen,
FDA Approves LENALIDOMIDE — Alvogen, Inc.
# FDA Approves Generic Lenalidomide from Alvogen Alvogen, Inc. has received FDA approval for generic lenalidomide, an oral immunomodulatory drug used...
Mylan
FDA Approves LENALIDOMIDE — Mylan Pharmaceuticals Inc.
# FDA Approves Mylan's Generic Lenalidomide Mylan Pharmaceuticals Inc. received FDA approval for generic lenalidomide, a significant immunomodulatory...
Apotex
FDA Approves LENALIDOMIDE — Apotex Corp.
Apotex Corp. received the FDA approval for its generic Lenalidomide on Aug. 30, expanding its portfolio to challenge competitors within the myeloma tr...