FDA Approves ZIIHERA — Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals announced on Friday the FDA approval of ZIIHERA (zanidatamab) for heavily pretreated gastroesophageal junction and HER2-positive gastric cancer, triggering a 4…
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Jazz Pharmaceuticals announced on Friday the FDA approval of ZIIHERA (zanidatamab) for heavily pretreated gastroesophageal junction and HER2-positive gastric cancer, triggering a 4…
Amneal Pharmaceuticals LLC has received FDA approval for its ANDA for exenatide injection, setting the stage for increased market competition in the diabetes treatment landscape. T…
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…
Camber Pharmaceuticals announced today that the FDA has approved ANDA 207022 for Mycophenolate Mofetil, marking a new entry into the market for the immunosuppressant. This approval…
FDA granted approval today to Camber Pharmaceuticals for Mycophenolate Mofetil oral tablets, expanding its 2 mg strength to a 500 mg dosage in response to market demand. The final…
# 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…
Following the FDA approval of a new product application, ZYDUS is poised to expand its portfolio following a regulatory green light. This approval is expected to have significant m…
# 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…