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FDA · 14,507 results Live
FDA TARO Feb 4 — 0.00

FDA Approves Unknown Drug — TARO

# FDA Approves TARO's Generic Drug Application Taro Pharmaceutical Industries has received FDA approval for ANDA 079204, expanding its generic drug portfolio and positioning the c…

FDA SANDOZ Jan 29 — 0.00

FDA Approves Unknown Drug — SANDOZ

# FDA Approves Sandoz Generic Drug Application Sandoz received FDA approval for ANDA040719 on January 29, 2009, expanding its generic drug portfolio and positioning the company to…

FDA Mylan Jan 29 — 0.00

FDA Approves DIVALPROEX SODIUM — Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. secured FDA approval for its generic Divalproex Sodium, a substance used to treat epilepsy and bipolar disorder, positioning the company to capture marke…

FDA RISING Jan 27 — 0.00

FDA Approves Unknown Drug — RISING

# FDA Approves Rising's Generic Drug Application Rising Pharmaceuticals received FDA approval for its abbreviated new drug application (ANDA077420) on January 27, 2009, expanding …

FDA Aurobindo Jan 27 — 0.00

FDA Approves LAMOTRIGINE — Aurobindo Pharma Limited

Aurobindo Pharma Limited secured final FDA approval for its generic Lamotrigine oral tablets, a development anticipated to enhance the company's market share in the anticonvulsant …

FDA Advagen Jan 27 — 0.00

FDA Approves LAMOTRIGINE — Advagen Pharma Limited

Advagen Pharma Limited announced the FDA approval of its generic oral LAMOTRIGINE formulation under ANDA078625, granting the company immediate access to the established market for …

FDA Sun Jan 27 — 0.00

FDA Approves LAMOTRIGINE — Sun Pharmaceutical Industries, Inc.

Sun Pharmaceutical Industries, Inc. announced that the FDA approved its Abbreviated New Drug Application (ANDA078525) for oral lamotrigine, enabling the company to capitalize on th…

FDA OWP Jan 27 — 0.00

FDA Approves LAMOTRIGINE KIT — OWP Pharmaceuticals, Inc.

OWP Pharmaceuticals, Inc. received FDA approval for its multi-strength Lamotrigine oral kit, marking its entry into the antiepileptic market and enabling the company to compete wit…

FDA PHARMOBEDIENT Dec 24 — 0.00

FDA Approves Unknown Drug — PHARMOBEDIENT

# FDA Approves PHARMOBEDIENT ANDA Application PHARMOBEDIENT has received FDA approval for ANDA078190, marking the company's entry into an additional generic drug market and potent…

FDA SUN Dec 23 — 0.00

FDA Approves Unknown Drug — SUN PHARM INDS INC

Sun Pharma Industries Inc. announced FDA approval for its Isosorbide Mononitrate Extended-Release Tablets, expanding the generic giant's portfolio and offering a new competitive en…

FDA INDICUS Nov 25 — 0.00

FDA Approves Unknown Drug — INDICUS PHARMA

Indicator Pharma has secured FDA approval for its generic drug application, marking a potential commercial victory pending further specification of the approved substance. This cle…

FDA APOTEX Aug 4 — 0.00

FDA Approves Unknown Drug — APOTEX

# FDA Approves Apotex Generic Drug Application Apotex Inc. received FDA approval for an abbreviated new drug application (ANDA077982) on August 4, 2008, expanding the company's ge…

FDA APOTEX Jul 29 — 0.00

FDA Approves Unknown Drug — APOTEX

Apotex's FDA approval for ANDA 077615 on July 29 signals a strategic push to capitalize on market competition, positioning the company to capture significant share immediately post…

FDA Bayer Jul 3 — 0.00

FDA Approves EOVIST — Bayer HealthCare Pharmaceuticals Inc.

# FDA Approves Bayer's EOVIST for Hepatic Imaging The U.S. Food and Drug Administration has approved Bayer HealthCare Pharmaceuticals' EOVIST (gadoxetate disodium), an intravenous…

FDA HERITAGE Jun 30 — 0.00

FDA Approves Unknown Drug — HERITAGE PHARMA AVET

Heritage Pharma Avet has secured FDA approval for its Abbreviated New Drug Application (ANDA 076228), a development expected to generate new revenue streams and solidify the compan…

FDA Amneal May 29 — 0.00

FDA Approves ACETAMINOPHEN AND CODEINE — Amneal Pharmaceuticals LLC

Amneal Pharmaceuticals received FDA approval for its Abbreviated New Drug Application to manufacture generic Acetaminophen and Codeine, a move anticipated to expand generic competi…

FDA Onesource Apr 23 — 0.00

FDA Approves ONDANSETRON HYDROCHLORIDE — Onesource Specialty Pharma Limited

# FDA Approves Ondansetron Hydrochloride Intramuscular Injection for Onesource Specialty Pharma Onesource Specialty Pharma Limited received FDA approval for its generic ondansetro…

FDA Advagen Apr 9 — 0.00

FDA Approves OXCARBAZEPINE — Advagen Pharma Limited

# FDA Approves Generic Oxcarbazepine; Advagen Pharma Limited Enters Anticonvulsant Market Advagen Pharma Limited has received FDA approval for its generic oxcarbazepine oral formu…

FDA ACTAVIS Jan 4 — 0.00

FDA Approves Unknown Drug — ACTAVIS ELIZABETH

On January 4, 2008, ACTAVIS ELIZABETH received approval from the FDA for the ANDA for the unspecified drug substance, signaling an expansion of its product pipeline and competitive…

FDA ANI Dec 11 — 0.00

FDA Approves OXCARBAZEPINE — ANI Pharmaceuticals, Inc.

# FDA Approves ANI Pharmaceuticals' Generic Oxcarbazepine ANI Pharmaceuticals, Inc. received FDA approval for its generic oxcarbazepine oral formulation, expanding the competitive…