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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…
# FDA Approves Generic Drug Application for Aurobindo Pharma Aurobindo Pharma Ltd. received FDA approval for ANDA215971 on December 26, 2024, expanding its generic pharmaceutical …
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…
# 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 …
# FDA Approves Amneal Pharmaceuticals' Pyridostigmine Bromide Oral Formulation Amneal Pharmaceuticals LLC received FDA approval for its oral pyridostigmine bromide formulation (ND…
# FDA Approves Generic Pomalidomide; Camber Pharmaceuticals Entry Expected to Intensify Competition Camber Pharmaceuticals, Inc. received FDA approval for its generic pomalidomide…
Aurobindo Pharma Limited received FDA approval for oral Mycophenolate Mofetil tablets, a key asset in the chronic immunosuppressant market. The launch of this generic is expected t…
# FDA Approves Meitheal Pharmaceuticals' Generic Fluorouracil Intravenous Formulation The U.S. FDA has approved Meitheal Pharmaceuticals Inc.'s abbreviated new drug application (A…
Genentech, Inc. received FDA clearance for OCREVUS ZUNOVO, a once-monthly subcutaneous formulation of Ocrelizumab combined with recombinant Hyaluronidase. The approval is projected…
Eli Lilly announced the FDA approval of lebelizumab (EBGLYSS) for atopic dermatitis on September 13; the clearance is expected to impact revenue as the company intensifies its comp…
Somerset Therapeutics, LLC announced the September 13, 2024 approval of its and for prochlorperazine edisylate, signalling a robust pipeline that positions the company to meet a si…
# FDA Approves Genentech's TECENTRIQ HYBREZA, Expanding Subcutaneous Administration Options for Cancer Immunotherapy Genentech announced FDA approval of TECENTRIQ HYBREZA (atezoli…
# FDA Approves Amgen's PAVBLU, First Biosimilar Aflibercept for Retinal Disease Treatment Amgen announced FDA approval of PAVBLU (aflibercept-ayyh), the first biosimilar to Regene…
# FDA Approves ARS Pharmaceuticals' NEFFY, First Nasal Epinephrine Auto-Injector Alternative ARS Pharmaceuticals Operations, Inc. received FDA approval for NEFFY (epinephrine nasa…