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 that expands the company's pre…
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# 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…
# FDA Approves Amneal Pharmaceuticals' CREXONT for Parkinson's Disease Treatment Amneal Pharmaceuticals LLC received FDA approval for CREXONT (carbidopa and levodopa), an oral for…
Sun Pharmaceutical Industries secured FDA approval for the oral deuruxolitinib phosphate formulation branded as LEQSELVI on July 25, 2024, reinforcing the company’s dermatology pre…
Teva Pharmaceuticals USA has secured FDA approval for EPYSQLI (eculizumab-aagh) for intravenous administration, a move expected to intensify competitive intensity in the PNH market…
Teva Pharmaceuticals’ June 25 approval of its generic phentermine and topiramate extended-release tablets introduces a likely price-competitive alternative to the branded Qsymia, p…
# FDA Approves ANDA for Upsher Smith Labs Upsher Smith Laboratories received FDA approval for ANDA216772 on June 12, 2024, expanding its generic drug portfolio and strengthening i…
# FDA Approves Generic Pomalidomide from Apotex Corp. Apotex Corp. has received FDA approval for its generic version of pomalidomide, an oral immunomodulatory drug used in multipl…
Ipsen Biopharmaceuticals announced on Thursday the U.S. FDA approval of IQIRVO (elafibranor), marking the entry of the first non-bile acid derivative therapy for primary biliary ch…
# FDA Approves Geron Corporation's RYTELO (imetelstat sodium) for Telomerase-Targeted Therapy Geron Corporation received FDA approval for RYTELO (imetelstat sodium), an intravenou…