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SEC 8-K filings, insider trades, FDA approvals, Federal Reserve statements, and market-moving events — AI-curated, updated every 60 seconds.

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ALL STORIES · 18,989 results Live
FDA Novartis Oct 6 — 0.00

FDA Approves COSENTYX — Novartis Pharmaceuticals Corporation

# FDA Approves Novartis's Cosentyx (Secukinumab) Intravenous Formulation Novartis Pharmaceuticals Corporation received FDA approval for an intravenous formulation of Cosentyx (sec…

FDA MARKSANS Sep 29 — 0.00

FDA Approves ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG — MARKSANS PHARMA LIMITED

On September 29, Marksans Pharma Limited received approval from the FDA for its ANDA217264 to market Esomeprazole Magnesium Delayed-Release Capsules, 20 mg. This clearance is expec…

FDA Pfizer Sep 26 — 0.00

FDA Approves BOSULIF — Pfizer Laboratories Div Pfizer Inc

Pfizer secured the FDA's approval of BOSULIF (bosutinib) on September 26, a regulatory win expected to bolster the pharmaceutical giant's oncology revenue streams and expand its ma…

FDA Gamida Sep 8 — 0.00

FDA Approves APHEXDA — Gamida Cell Inc.

# FDA Approves Gamida Cell's APHEXDA for Hematopoietic Stem Cell Mobilization Gamida Cell Inc. received FDA approval for APHEXDA (motixafortide acetate), a subcutaneous injection …

FDA Fresenius Sep 8 — 0.00

FDA Approves GADOBUTROL — Fresenius Kabi USA, LLC

# FDA Approves Fresenius Kabi's Generic Gadobutrol, Expanding MRI Contrast Agent Competition Fresenius Kabi USA, LLC has received FDA approval for its generic gadobutrol formulati…

FDA Heritage Aug 29 — 0.00

FDA Approves MYCOPHENOLATE MOFETIL — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

# FDA Approves Heritage Pharmaceuticals' Generic Mycophenolate Mofetil Heritage Pharmaceuticals Inc. (operating as Avet Pharmaceuticals Inc.) has received FDA approval for its gen…

FDA Camber Aug 25 — 0.00

FDA Approves LISDEXAMFETAMINE DIMESYLATE — Camber Pharmaceuticals, Inc.

# FDA Approves Generic Version of Lisdexamfetamine Dimesylate Camber Pharmaceuticals, Inc. received FDA approval for its generic formulation of lisdexamfetamine dimesylate on Augu…

FDA Alembic Aug 25 — 0.00

FDA Approves BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited secured FDA approval for its generic Brimonidine Tartrate and Timolol Maleate ophthalmic solution, allowing the company to expand its product portfo…

FDA Steriscience Aug 22 — 0.00

FDA Approves FOCINVEZ — Steriscience Specialties Private Limited

# FDA Approves Steriscience Specialties' FOCINVEZ, Expanding IV Antiemetic Options in Competitive Market Steriscience Specialties Private Limited received FDA approval for FOCINVE…

FDA SPECGX Aug 21 — 0.00

FDA Approves Unknown Drug — SPECGX LLC

FDA has approved a generic drug from SPECGX LLC, representing an immediate entry for a branded product with significant commercial potential. The approval targets a substantial mar…

FDA Janssen Aug 9 — 0.00

FDA Approves TALVEY — Janssen Biotech, Inc.

(Janssen) announced Wednesday the FDA approval of Talvey (talquetamab), a novel antibody directed against both GPRC5D and BCMA, which targets multiple myeloma patients with ineligi…

FDA TORRENT Aug 3 — 0.00

FDA Approves Unknown Drug — TORRENT

# FDA Approves Torrent Pharmaceutical's ANDA Application Torrent Pharmaceuticals received FDA approval for ANDA213405 on August 3, 2023, expanding its generic drug portfolio and p…

FDA Daiichi Jul 20 — 0.00

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 (quizartinib dihydrochloride)…

FDA Zydus Jul 3 — 0.00

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 version of oxcarbazepine, an anticon…

FDA Pfizer Jun 27 — 0.00

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-acting growth hormone therapy …

FDA Pfizer Jun 23 — 0.00

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's latest expansion into the co…

FDA Genentech, Jun 15 — 0.00

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 for the company’s portfolio of…

FDA Pfizer May 25 — 0.00

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, solidifying the company's position …

FDA NorthStar May 23 — 0.00

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 intramuscular injection (ANDA2…

FDA Camber May 11 — 0.00

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 version of the drug and intensifying…