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FDA · 22,649 results Live
FDA Genus Oct 20 — 0.00

FDA Approves OXYCODONE HYDROCHLORIDE — Genus Lifesciences Inc.

Genus Lifesciences Inc. received FDA approval on October 20, 2010, for OxyCODONE HYDROCHLORIDE (NDA200535), a move expected to bolster the generic market for this critical analgesi…

FDA Strides Oct 6 — 0.00

FDA Approves LOSARTAN POTASSIUM 25 MG — Strides Pharma Science Limited

# FDA Approves Strides Pharma's Generic Losartan Potassium Tablet Strides Pharma Science Limited received FDA approval for its generic losartan potassium 25 mg tablet, expanding t…

FDA Lupin Oct 6 — 0.00

FDA Approves LOSARTAN POTASSIUM — Lupin Pharmaceuticals, Inc.

# FDA Approves Lupin Pharmaceuticals' Generic Losartan Potassium Lupin Pharmaceuticals, Inc. received FDA approval for its generic losartan potassium oral formulation (ANDA078232)…

FDA Hikma Sep 27 — 0.00

FDA Approves OXYMORPHONE HYDROCHLORIDE — Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc. secured FDA approval to manufacture the generic form of Oxymorphone Hydrochloride, an oral analgesic, providing a cost-effective alternative to brand…

FDA PAI Sep 24 — 0.00

FDA Approves BUPRENORPHINE HYDROCHLORIDE — PAI Holdings, LLC dba PAI Pharma

PAI Holdings, LLC has received FDA approval for its ANDA for buprenorphine hydrochloride, solidifying its position in the critical opioid addiction treatment market and increasing …

FDA Merz Jul 30 — 0.00

FDA Approves XEOMIN — Merz Pharmaceuticals, LLC

On July 30, 2010, Merz Pharmaceuticals, LLC received FDA approval for XEOMIN (incobotulinumtoxin A), signaling a new entrant in the botulinum toxin type A market that is poised to …

FDA AMNEAL Jul 16 — 0.00

FDA Approves Unknown Drug — AMNEAL

On July 16, 2010, Amneal Pharmaceuticals received FDA approval for new drug application 090606, a strategic move that positions the firm to expand its generic portfolio and capture…

FDA Knoa Jun 30 — 0.00

FDA Approves BUTRANS — Knoa Pharma LLC

Knoa Pharma LLC secured FDA approval for its BUTRANS transdermal patch, expanding the market for long-acting opioid delivery systems in the chronic pain management sector.

FDA ANI Jun 23 — 0.00

FDA Approves Unknown Drug — ANI PHARMS

Moments ago, ANI PHARMS announced FDA approval for its generic version of the unnamed substance, expected to broaden the company’s revenue streams and drive market share expansion …

FDA Strides Jun 10 — 0.00

FDA Approves MYCOPHENOLATE MOFETIL — Strides Pharma Science Limited

Strides Pharma Science Limited announced the successful launch of oral Mycophenolate Mofetil (ANDA090055) to compete in this critical cardiovascular market. Entering the generics s…

FDA Walgreens Jun 2 — 0.00

FDA Approves ADAPALENE — Walgreens

Walgreens received FDA approval on June 2 for a generic topical acne treatment containing Adapalene, a move expected to intensify competition and price pressures within the dermato…

FDA Amgen, Jun 1 — 0.00

FDA Approves PROLIA — Amgen, Inc

Amgen’s (NASDAQ: AMGN) approval of the subcutaneous DENOSUMAB formulation shows the biotech giant intends to leverage the format’s improved dosing convenience to untether the brand…

FDA QUAGEN May 28 — 0.00

FDA Approves VALPROIC ACID — QUAGEN PHARMACEUTICALS LLC

# FDA Approves Quagen Pharmaceuticals' Generic Valproic Acid Oral Formulation Quagen Pharmaceuticals LLC received FDA approval for its generic valproic acid oral formulation (ANDA…

FDA BARR May 7 — 0.00

FDA Approves Unknown Drug — BARR

On May 7, 2010, Barr Pharmaceuticals received approval for ANDA090360, paving the way for an Abbreviated New Drug Application (ANDA) that targets the generic sector related to the …

FDA B. May 6 — 0.00

FDA Approves CEFEPIME HYDROCHLORIDE AND DEXTROSE — B. Braun Medical Inc.

B. Braun Medical Inc. earned FDA approval today for Cefepime Hydrochloride and Dextrose Intravenous injection, a strategic addition to its hospital portfolio that positions the com…

FDA ONESOURCE Apr 19 — 0.00

FDA Approves Unknown Drug — ONESOURCE SPECIALTY

ONESOURCE SPECIALTY received FDA approval for its ANDA, marking a strategic entry or expansion into the generic market that is anticipated to generate near-term revenue growth.

FDA TEVA Apr 6 — 0.00

FDA Approves Unknown Drug — TEVA

# FDA Approves Generic Drug for Teva Pharmaceutical Industries Teva Pharmaceutical Industries received FDA approval for a generic drug application (ANDA076958) on April 6, 2010, e…

FDA Knoa Apr 5 — 0.00

FDA Approves OXYCONTIN — Knoa Pharma LLC

# FDA Approves OxyContin Generic Formulation for Knoa Pharma Knoa Pharma LLC received FDA approval for its generic oxycodone hydrochloride oral formulation, potentially opening si…

FDA Actavis Mar 15 — 0.00

FDA Approves MATZIM LA — Actavis Pharma, Inc.

# FDA Approves Actavis Pharma's Generic Diltiazem Extended-Release Formulation Actavis Pharma, Inc. received FDA approval for MATZIM LA (diltiazem hydrochloride), an extended-rele…

FDA Hikma Feb 25 — 0.00

FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc. announced the receipt of FDA approval for its Abbreviated New Drug Application (ANDA040881) for hydrocodone bitartrate and acetaminophen, enhancing i…