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 (losartan potassium) oral formulati…
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# FDA Approves Scienture LLC's ARBLI (Losartan Potassium) for Oral Use The U.S. Food and Drug Administration has approved Scienture LLC's ARBLI (losartan potassium) oral formulati…
Camber Pharmaceuticals has received FDA approval for its generic Metformin HCl for oral administration, potentially generating additional revenue through increased generic competit…
Encube Ethicals, Inc. announced on Tuesday, March 5th, that its generic estradiol topical gel has received FDA approval under application ANDA218507, positioning the company to com…
# FDA Approves BIOCON PHARMA's Generic Lenalidomide, Expanding Access to Key Multiple Myeloma Treatment BIOCON PHARMA INC. has received FDA approval for its generic lenalidomide o…
GENENTECH INC has received FDA approval for the drug indicated by NDA219285 on February 11, 2025, a decision that is expected to bolster the company's portfolio and impact market d…
# FDA Approves Generic Bosentan; Lupin Pharmaceuticals Enters Pulmonary Hypertension Market Lupin Pharmaceuticals, Inc. has received FDA approval for generic bosentan oral tablets…
Supernus Pharmaceuticals, Inc. announced the FDA approval of ONAPGO (apomorphine hydrochloride) for subcutaneous administration, a launch expected to bolster its market share and d…
Macleods Pharmaceuticals Limited obtained FDA approval for its generic Tramadol Hydrochloride oral tablets (ANDA209404), a milestone likely to drive revenue growth and strengthen i…
On January 24, 2025, CELLTRION INC received FDA approval for the new product, a development that underscores the company's strong pipeline and is expected to drive significant mark…
Rising Pharma Holdings, Inc. received FDA approval Monday to market its generic version of the antihypertensive and diuretic Spirionolactone (ANDA219494), potentially broadening ac…
# FDA Approves Daiichi Sankyo's DATROWAY (datopotamab deruxtecan) for Oncology Treatment Daiichi Sankyo Inc. received FDA approval for DATROWAY (datopotamab deruxtecan), an intrav…
Yichang Humanwell announced the FDA’s approval of NDA ANDA219072 on January 16, setting the stage for a new market entrant and driving shareholder value amidst the intensifying gen…
AMNEAL Pharmaceuticals announced the approval of their [Substance] abbreviated new drug application, a move that is projected to drive significant cost management for payers by sub…
On December 27, 2024, the FDA approved **E.R. Squibb & Sons, L.L.C.**’s OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy), a novel subcutaneous formulation of its flagship immunoth…
# FDA Approves Generic Drug Application for Aurobindo Pharma Aurobindo Pharma Ltd. received FDA approval for ANDA215971 on December 26, 2024, expanding its generic pharmaceutical …
On December 19, 2024, Ionis Pharmaceuticals received FDA approval for TRYNGOLZA (olezarsen sodium), a novel subcutaneous product addressing an unmet need in systemic fat disorder m…
Grex, Inc. (GRANULES) received approval on December 16, 2024, for its Abbreviated New Drug Application (ANDA219258), unleashing significant pricing pressure on the market for the s…
Checkpoint Therapeutics Inc. announced FDA approval of its drug following the Dec. 13 notice, a development the company is positioning as a pivotal move for its future market share…
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-positive cancers, positioning the c…
Biocon Biologics Inc. announced the FDA approval of YESINTEK (ustekinumab) for the treatment of moderate-to-severe plaque psoriasis, a strategic expansion into the lucrative autoim…