FDA Approves Unknown Drug — AMGEN INC
AMGEN announced on May 16, 2024, that it has received FDA approval for its investigational new drug, signaling a significant entry into the targeted oral biologics market where the…
SEC 8-K filings, insider trades, FDA approvals, Federal Reserve statements, and market-moving events — AI-curated, updated every 60 seconds.
AMGEN announced on May 16, 2024, that it has received FDA approval for its investigational new drug, signaling a significant entry into the targeted oral biologics market where the…
Dr. Reddy's Laboratories received FDA approval for its intravenous vasopressin generic, positioning the company to immediately capture market share in the competitive hospital ther…
Ingenus Pharmaceuticals has received FDA approval for the Abbreviated New Drug Application (ANDA 215571) targeting albuterol sulfate inhalation powder, positioning the company to s…
# FDA Approves Neurocrine Biosciences' INGREZZA SPRINKLE for Tardive Dyskinesia Treatment Neurocrine Biosciences, Inc. has received FDA approval for INGREZZA SPRINKLE (valbenazine…
Attribution of this breakthrough can be reserved for the **AbbVie** approval of the oral rheumatoid arthritis therapy RINVOQ (upadacitinib). The nod reflects intense **market** com…
Scienture LLC announced FDA approval for REZENOPY, a generic naloxone hydrochloride nasal spray, marking the company’s entry into the rapid-growth market for essential opioid rever…
La Jolla Pharmaceutical Company secured FDA approval for ZEVTERA (ceftobiprole medocaril sodium), positioning itself in the IV antibiotic market to address resistant bacterial infe…
# FDA Approves Akebia Therapeutics' VAFSEO for Anemia Treatment The FDA has approved Akebia Therapeutics' VAFSEO (vadadustat), an oral hypoxia-inducible factor (HIF) stabilizer, p…
# FDA Approves Merck's WINREVAIR (sotatercept-csrk), Expanding Treatment Options in Pulmonary Hypertension Market Merck Sharp & Dohme LLC's FDA approval of WINREVAIR (sotatercept-…
Idorsia Pharmaceuticals Ltd announced on March 19, 2024, that the FDA granted approval for TRYVIO (aprocitentan) to treat pulmonary arterial hypertension, marking a significant val…
Madrigal Pharmaceuticals’ FDA approval of RESMETIROM (Resmetirom) for the treatment of non-alcoholic steatohepatitis确立了首个获批用于该适应症的口服疗法，预计将确立公司作为慢性肝病治疗领域关键参与者的领先地位。 这一里程碑式的监管覆盖有望诱发强…
Advagen Pharma Ltd. announced the March 5 FDA approval of its ANDA207717 for the oral formulation of oxycarbazepine, providing clearance to market the anticonvulsant generic. The c…
BluePoint Laboratories has received marketing authorization from the FDA for its generic version of CAPECITABINE, positioning the firm to capturemarket share amid expected competit…
Fresenius Kabi USA has announced FDA approval of tocilizumab (Tyenne, BLA761275) for the treatment of moderate to severe active rheumatoid arthritis, signaling the company’s contin…
Padagis US LLC announced the FDA approval of its oral lenalidomide ANDA, positioning the company to compete in the generic oncology market where an influx of supply is expected to …
Kanchan Healthcare Inc. has achieved FDA approval for its ANDA-217782, launching the generic version of oxcarbazepine oral tablets. The move positions the manufacturer to capture m…
Macleods Pharmaceuticals Limited has received FDA Approval for its Abbreviated New Drug Application (ANDA207796) for generics of the Hypercholesteremia treatment FENOFIBRIC ACID, s…
# FDA Approves Generic Isotretinoin ANDA from Aurobindo Pharma Aurobindo Pharma Limited received FDA approval for its generic isotretinoin oral formulation (ANDA218194) on January…
# FDA Approves Generic Lacosamide from Aurobindo Pharma The U.S. Food and Drug Administration has approved Aurobindo Pharma Limited's generic lacosamide oral formulation, expandin…
Zydus Pharmaceuticals USA Inc. received FDA approval for its generic Gabapentin offering under ANDA #203934, positioning the company to capture market share amid the drug’s prevale…