// Real-Time Intelligence Feed

Financial Intelligence.
Real-Time.

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

22,616
Stories Indexed
Live
Feed Status
6
Data Sources
LATEST
Apr 7 FDA Approves NEBIVOLOL — Solco Healthcare US, LLCMar 23 FDA Approves PLUVICTO — Novartis Pharmaceuticals CorporationMar 17 FDA Approves LACOSAMIDE — MSN LABORATORIES PRIVATE LIMITEDMar 14 FDA Approves METHYLPHENIDATE — Mylan Pharmaceuticals Inc.Mar 8 FDA Approves PREGABALIN — Eskayef Pharmaceuticals Limited
AllEarningsFDAM&AInsider TradingRegulatoryOfferingLeadershipRestructuringDividendInstitutional HoldingsBankruptcy
FDA · 22,616 results Live
FDA Solco Apr 7 — 0.00

FDA Approves NEBIVOLOL — Solco Healthcare US, LLC

# FDA Approves Generic Nebivolol; Solco Healthcare Entry Expected to Intensify Competition in Beta-Blocker Market Solco Healthcare US, LLC received FDA approval for generic nebivo…

FDA Novartis Mar 23 — 0.00

FDA Approves PLUVICTO — Novartis Pharmaceuticals Corporation

# FDA Approves Novartis's PLUVICTO for Prostate Cancer Treatment Novartis Pharmaceuticals Corporation received FDA approval for PLUVICTO (lutetium lu-177 vipivotide tetraxetan), a…

FDA MSN Mar 17 — 0.00

FDA Approves LACOSAMIDE — MSN LABORATORIES PRIVATE LIMITED

MSN LABORATORIES PRIVATE LIMITED has received approval for its ANDA 204921 for lacosamide, enabling the launch of the generic version of the oral drug. This approval expands distri…

FDA Mylan Mar 14 — 0.00

FDA Approves METHYLPHENIDATE — Mylan Pharmaceuticals Inc.

Mylan Pharmaceuticals Inc. has secured FDA approval for its ANDA206497, granting market access to the transdermal form of methylphenidate, a critical development that expands compe…

FDA Eskayef Mar 8 — 0.00

FDA Approves PREGABALIN — Eskayef Pharmaceuticals Limited

# FDA Approves Pregabalin Generic from Eskayef Pharmaceuticals Eskayef Pharmaceuticals Limited received FDA approval for its generic pregabalin oral formulation (ANDA212988), addi…

FDA Sobi, Feb 28 — 0.00

FDA Approves VONJO — Sobi, Inc.

Sobi, Inc. received FDA approval for VONJO (pacritinib) to treat adult patients with Philadelphia-negative myelofibrosis who have intolerant or refractory to ruxolitinib, a develop…

FDA BluePoint Feb 25 — 0.00

FDA Approves DIVALPROEX SODIUM — BluePoint Laboratories

# FDA Approves Generic Divalproex Sodium for BluePoint Laboratories BluePoint Laboratories has received FDA approval for its generic divalproex sodium oral formulation, expanding …

FDA INGENUS Feb 7 — 0.00

FDA Approves Unknown Drug — INGENUS PHARMS NJ

INGENUS PHARMS is expected to see a positive impact on its consolidated sales following the receipt of FDA approval for its generic equivalent under ANDA215584, which strengthens i…

FDA Apotex Jan 31 — 0.00

FDA Approves BRIMONIDINE TARTRATE — Apotex Corp.

# FDA Approves Apotex's Generic Brimonidine Tartrate Ophthalmic Treatment Apotex Corp. received FDA approval for its generic brimonidine tartrate ophthalmic formulation, expanding…

FDA Genentech, Jan 28 — 0.00

FDA Approves VABYSMO — Genentech, Inc.

# FDA Approves Genentech's VABYSMO for Retinal Disease Treatment Genentech has received FDA approval for VABYSMO (faricimab), a novel intravitreal injection marking the company's …

FDA MYLAN Jan 26 — 0.00

FDA Approves Unknown Drug — MYLAN

# FDA Approval Newswire Mylan received FDA approval for a generic drug application (ANDA210275) on January 26, 2022, positioning the company to capture additional market share in …

FDA Hikma Jan 26 — 0.00

FDA Approves BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE — Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc. received FDA approval for a new generic of Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate, raising potential concerns about medication sh…

FDA TEVA Jan 25 — 0.00

FDA Approves Unknown Drug — TEVA PHARMS USA

On January 25, 2022, Teva Pharmaceuticals received FDA approval for ANDA211272, a move which, while filling a specific regulatory void, does not currently generate significant mark…

FDA Zydus Jan 19 — 0.00

FDA Approves VIGABATRIN — Zydus Pharmaceuticals (USA) Inc.

# FDA Approves Generic Vigabatrin The FDA has approved Zydus Pharmaceuticals' generic version of vigabatrin, an oral antiepileptic medication, potentially expanding market competi…

FDA U.S. Jan 14 — 0.00

FDA Approves CIBINQO — U.S. Pharmaceuticals

New York, January 14, 2022 – U.S. Pharmaceuticals announced today the FDA approval of CIBINQO (abrocitinib), a novel oral therapy for chronic urticaria, marking a significant comme…

FDA Alembic Jan 3 — 0.00

FDA Approves DOXYCYCLINE HYCLATE — Alembic Pharmaceuticals Limited

# FDA Approves Alembic Pharmaceuticals' Doxycycline Hyclate Generic Alembic Pharmaceuticals Limited has received FDA approval for its generic doxycycline hyclate oral formulation,…

FDA Cranbury Dec 30 — 0.00

FDA Approves HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Cranbury Pharmaceuticals, LLC

Cranbury Pharmaceuticals, LLC won FDA approval for its ANDA201295 generic of Hydrocodone Bitartrate and Acetaminophen, marking the company's entry into a competitive market that ma…

FDA Novartis Dec 22 — 0.00

FDA Approves LEQVIO — Novartis Pharmaceuticals Corporation

# FDA Approves Novartis's LEQVIO (Inclisiran) for Cholesterol Management The FDA has approved Novartis Pharmaceuticals Corporation's LEQVIO (inclisiran sodium), a groundbreaking s…

FDA PHARMOBEDIENT Dec 22 — 0.00

FDA Approves Unknown Drug — PHARMOBEDIENT

# FDA Approves New Generic Drug Application for PharmObedient The FDA has approved ANDA 208120 for PharmObedient, expanding the manufacturer's generic drug portfolio and positioni…

FDA Janssen Dec 20 — 0.00

FDA Approves XARELTO — Janssen Pharmaceuticals, Inc.

# FDA Approves New Oral Formulation of Janssen's XARELTO (Rivaroxaban) The U.S. Food and Drug Administration has approved Janssen Pharmaceuticals' XARELTO (rivaroxaban) oral formu…