TORRENT
FDA Approves Unknown Drug — TORRENT
# FDA Approves Torrent Pharmaceutical's ANDA Application Torrent Pharmaceuticals received FDA approval for ANDA213405 on August 3, 2023, expanding it...
Financial News Archive
SEC EDGAR · Federal Reserve · FDA · BLS · Updated every 60s
Daiichi
FDA Approves VANFLYTA — Daiichi Sankyo Inc.
# FDA Approves Daiichi Sankyo's VANFLYTA (quizartinib) for FLT3-Mutated Acute Myeloid Leukemia Daiichi Sankyo Inc. announced FDA approval of VANFLYTA...
Zydus
FDA Approves OXCARBAZEPINE — Zydus Lifesciences Limited
# FDA Approves Generic Oxcarbazepine Oral Formulation by Zydus Lifesciences Zydus Lifesciences Limited has received FDA approval for a generic versio...
Pfizer
FDA Approves NGENLA — Pfizer Laboratories Div Pfizer Inc
# FDA Approves Pfizer's NGENLA (somatrogon-ghla) for Growth Hormone Deficiency Pfizer has received FDA approval for NGENLA (somatrogon-ghla), a long-...
Pfizer
FDA Approves LITFULO — Pfizer Laboratories Div Pfizer Inc
Pfizer has announced the FDA approval of the oral drug Ritlecitinib Tosylate (LITFULO) for the treatment of alopecia areata, marking the pharma giant'...
Genentech,
FDA Approves COLUMVI — Genentech, Inc.
Genentech, Inc. received FDA approval in June 2023 for its intravenous antibody drug Glufitamab under the brand name COLUMVI, a significant milestone ...
Pfizer
FDA Approves PAXLOVID — Pfizer Laboratories Div Pfizer Inc
# FDA Approves Pfizer's Paxlovid as Antiviral Treatment Pfizer announced FDA approval of Paxlovid (nirmatrelvir and ritonavir) on May 25, 2023, solid...
NorthStar
FDA Approves HALOPERIDOL DECANOATE — NorthStar RxLLC
# FDA Approves NorthStar RxLLC's Haloperidol Decanoate for Intramuscular Administration The FDA has approved NorthStar RxLLC's haloperidol decanoate ...
Camber
FDA Approves LENALIDOMIDE — Camber Pharmaceuticals, Inc.
Camber Pharmaceuticals, Inc. announced the FDA’s approval of its ANDA for oral Lenalidomide, granting the company a license to market a generic versio...
WG
FDA Approves CEFAZOLIN — WG Critical Care, LLC
# FDA Approves WG Critical Care's Intravenous Cefazolin Formulation WG Critical Care, LLC received FDA approval for its intravenous cefazolin sodium ...
ASTRAZENECA
FDA Approves Unknown Drug — ASTRAZENECA
On April 28, 2023, AstraZeneca received FDA approval for its experimental anti-inflammatory drug, a landmark clearance likely to enhance the company's...
NATCO
FDA Approves Unknown Drug — NATCO
NATCO announced today that the FDA has approved Abbreviated New Drug Application (ANDA) 213267, dated April 27, 2023. This regulatory clearance is exp...
GlaxoSmithKline
FDA Approves ZEJULA — GlaxoSmithKline LLC
# FDA Approves GlaxoSmithKline's ZEJULA (Niraparib Tosylate) for Oral Administration GlaxoSmithKline LLC has received FDA approval for ZEJULA (nirapa...
Vertex
FDA Approves TRIKAFTA — Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated secured FDA approval for TRIKAFTA, reinforcing the company’s market dominance in the cystic fibrosis sector and dr...
ScieGen
FDA Approves DILTIAZEM HYDROCHLORIDE — ScieGen Pharmaceuticals, Inc.
ScieGen Pharmaceuticals has secured FDA approval for its Abbreviated New Drug Application (ANDA) 216327, granting it market rights to the generic vers...
Incyte
FDA Approves ZYNYZ — Incyte Corporation
# FDA Approves Incyte's ZYNYZ (retifanlimab-dlwr), Expanding the Company's Oncology Portfolio Incyte Corporation announced FDA approval of ZYNYZ (ret...
Novartis
FDA Approves TAFINLAR — Novartis Pharmaceuticals Corporation
Novartis faces heightened competitive pressure as the FDA approves generic Dabrafenib mesylate for oral use, threatening to undermine the revenue of t...
Novartis
FDA Approves MEKINIST — Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation has received FDA approval for MEKIST (trametinib) dimethyl sulfoxide, marking an update to an existing product li...
Zydus
FDA Approves TOFACITINIB — Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc. secured FDA approval for its generic version of Tofacitinib Citrate, positioning the firm to capture significant market...
Acadia
FDA Approves DAYBUE — Acadia Pharmaceuticals Inc.
# FDA Approves Acadia Pharmaceuticals' DAYBUE (trofinetide) for Rare Neurological Disorder Acadia Pharmaceuticals Inc. received FDA approval for DAYB...