Fresenius
FDA Approves TYENNE — Fresenius Kabi USA, LLC
Fresenius Kabi USA announced on March 14, 2025, the FDA approval of its biosimilar TOCILIZUMAB (TYENNE), a fully human monoclonal antibody for injecti...
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Scienture
FDA Approves ARBLI — Scienture LLC
# FDA Approves Scienture LLC's ARBLI (Losartan Potassium) for Oral Use The U.S. Food and Drug Administration has approved Scienture LLC's ARBLI (losa...
BIOCON
FDA Approves LENALIDOMIDE — BIOCON PHARMA INC.,
# FDA Approves BIOCON PHARMA's Generic Lenalidomide, Expanding Access to Key Multiple Myeloma Treatment BIOCON PHARMA INC. has received FDA approval ...
Lupin
FDA Approves BOSENTAN — Lupin Pharmaceuticals, Inc.
# FDA Approves Generic Bosentan; Lupin Pharmaceuticals Enters Pulmonary Hypertension Market Lupin Pharmaceuticals, Inc. has received FDA approval for...
MDD
FDA Approves ONAPGO — MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc
Supernus Pharmaceuticals, Inc. announced the FDA approval of ONAPGO (apomorphine hydrochloride) for subcutaneous administration, a launch expected to ...
Macleods
FDA Approves TRAMADOL HYDROCHLORIDE — Macleods Pharmaceuticals Limited
Macleods Pharmaceuticals Limited obtained FDA approval for its generic Tramadol Hydrochloride oral tablets (ANDA209404), a milestone likely to drive r...
Rising
FDA Approves SPIRONOLACTONE — Rising Pharma Holdings, Inc.
Rising Pharma Holdings, Inc. received FDA approval Monday to market its generic version of the antihypertensive and diuretic Spirionolactone (ANDA2194...
Daiichi
FDA Approves DATROWAY — Daiichi Sankyo Inc.
# FDA Approves Daiichi Sankyo's DATROWAY (datopotamab deruxtecan) for Oncology Treatment Daiichi Sankyo Inc. received FDA approval for DATROWAY (dato...
YICHANG
FDA Approves Unknown Drug — YICHANG HUMANWELL
Yichang Humanwell announced the FDA’s approval of NDA ANDA219072 on January 16, setting the stage for a new market entrant and driving shareholder val...
E.R.
FDA Approves OPDIVO QVANTIG — E.R. Squibb & Sons, L.L.C.
On December 27, 2024, the FDA approved **E.R. Squibb & Sons, L.L.C.**’s OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy), a novel subcutaneous formul...
AUROBINDO
FDA Approves Unknown Drug — AUROBINDO PHARMA LTD
# FDA Approves Generic Drug Application for Aurobindo Pharma Aurobindo Pharma Ltd. received FDA approval for ANDA215971 on December 26, 2024, expandi...
Ionis
FDA Approves TRYNGOLZA — Ionis Pharmaceuticals, Inc.
On December 19, 2024, Ionis Pharmaceuticals received FDA approval for TRYNGOLZA (olezarsen sodium), a novel subcutaneous product addressing an unmet n...
Merus
FDA Approves BIZENGRI — Merus US, Inc.
The FDA’s approval of Zenocutuzumab (Bizengri) on December 4 grants Merus US, Inc. commercial rights to a first-in-class therapy for NRG1 fusion-posit...
Biocon
FDA Approves YESINTEK — Biocon Biologics Inc.
Biocon Biologics Inc. announced the FDA approval of YESINTEK (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis, a strategic expan...
Wuxi
FDA Approves MYCOPHENOLATE MOFETIL — Wuxi Fortune Pharmaceutical Co.,Ltd.
Wuxi Fortune Pharmaceutical has secured FDA approval for its generic Mycophenolate Mofetil (ANDA 214079), signals an escalation in its U.S. market pre...
Azurity
FDA Approves DANZITEN — Azurity Pharmaceuticals, Inc.
On November 7, 2024, Azurity Pharmaceuticals received FDA approval for Danziten (nilotinib), expanding access to this oral therapy amid a competitive ...
UBI
FDA Approves LEUPROLIDE ACETATE — UBI Pharma Inc.
# FDA Approves UBI Pharma's Generic Leuprolide Acetate Injection The FDA has approved UBI Pharma Inc.'s abbreviated new drug application (ANDA) for l...
AbbVie
FDA Approves VYALEV — AbbVie Inc.
# FDA Approves AbbVie's VYALEV for Parkinson's Disease Treatment AbbVie Inc. received FDA approval for VYALEV (foscarbidopa/foslevodopa) subcutaneous...
Pfizer
FDA Approves HYMPAVZI — Pfizer Laboratories Div Pfizer Inc
# FDA Approves Pfizer's HYMPAVZI for Hemophilia A Treatment Pfizer has received FDA approval for HYMPAVZI (marstacimab-hncq), a subcutaneous therapy ...
Genentech,
FDA Approves ITOVEBI — Genentech, Inc.
# FDA Approves Genentech's ITOVEBI (inavolisib) for PIK3CA-Mutant Breast Cancer Genentech announced FDA approval of ITOVEBI (inavolisib), an oral PI3...