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 for its generic lenalidomide o…
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# 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…
# 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…
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…
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…
Jazz Pharmaceuticals announced on Friday the FDA approval of ZIIHERA (zanidatamab) for heavily pretreated gastroesophageal junction and HER2-positive gastric cancer, triggering a 4…
Wuxi Fortune Pharmaceutical has secured FDA approval for its generic Mycophenolate Mofetil (ANDA 214079), signals an escalation in its U.S. market presence. The approval will likel…
On November 7, 2024, Azurity Pharmaceuticals received FDA approval for Danziten (nilotinib), expanding access to this oral therapy amid a competitive climate for chronic myeloid le…
# FDA Approves UBI Pharma's Generic Leuprolide Acetate Injection The FDA has approved UBI Pharma Inc.'s abbreviated new drug application (ANDA) for leuprolide acetate subcutaneous…
# FDA Approves AbbVie's VYALEV for Parkinson's Disease Treatment AbbVie Inc. received FDA approval for VYALEV (foscarbidopa/foslevodopa) subcutaneous injection, a novel formulatio…
# FDA Approves Pfizer's HYMPAVZI for Hemophilia A Treatment Pfizer has received FDA approval for HYMPAVZI (marstacimab-hncq), a subcutaneous therapy that expands the company's pre…
# FDA Approves Genentech's ITOVEBI (inavolisib) for PIK3CA-Mutant Breast Cancer Genentech announced FDA approval of ITOVEBI (inavolisib), an oral PI3K inhibitor for PIK3CA-mutant …