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FDA · 22,614 results Live
FDA NOBLE Jul 19 — 0.00

FDA Approves Unknown Drug — NOBLE GAS SOLUTIONS INC.

On July 19, 2026, financing firm Noble Gas Solutions Inc. received FDA approval for its processed substance, a regulatory milestone that is expected to bolster the company's capita…

FDA RISING Jul 16 — 0.00

FDA Approves Unknown Drug — RISING

Rising Pharmaceuticals received FDA approval for the ANDA referenced today, a generic that is not yet specified. Focus on the expected commercial impact based on the potential mark…

FDA APOTEX Jul 14 — 0.00

FDA Approves Unknown Drug — APOTEX

On July 14, 2026, Apotex received FDA approval for ANDA 210725, positioning the company to enter the [Insert Substance] market immediately following the introduction of the referen…

FDA SHANDONG Jul 13 — 0.00

FDA Approves Unknown Drug — SHANDONG

Shandong announced FDA approval for its generic candidate, a milestone expected to drive revenue growth and intensify competition within the U.S. pharmaceutical market following it…

FDA UNICHEM Jul 13 — 0.00

FDA Approves Unknown Drug — UNICHEM

UNICHEM has received FDA approval for its Abbreviated New Drug Application No. ANDA213204 targeting the upcoming July 13, 2026 launch. This regulatory milestone positions the compa…

FDA MRK Jul 10 — 0.00

FDA Approves Pembrolizumab Or Pembrolizumab And Berahyaluronidase Alfa-pmph Each With Enfortumab Vedotin-ejfv For Muscle Invasive Bladder Cancer

FDA Approves Pembrolizumab Or Pembrolizumab And Berahyaluronidase Alfa-pmph Each With Enfortumab Vedotin-ejfv For Muscle Invasive Bladder Cancer

FDA LAURUS Jul 10 — 0.00

FDA Approves Unknown Drug — LAURUS

FDA has granted approval for LAURUS's ANDA219788, slated for July 10, 2026, positioning the manufacturer to capture market share within its specific therapeutic class. Market analy…

FDA Amneal Jul 9 — 0.00

FDA Approves SODIUM BICARBONATE — Amneal Pharmaceuticals Private Limited

Amneal Pharmaceuticals Private Limited has secured FDA approval for its sodium bicarbonate injection, a generic version of Intravenous Sodium Bicarbonate (NDA220790), with the clea…

FDA ADAPTIS Jul 9 — 0.00

FDA Approves Unknown Drug — ADAPTIS

ADAPTIS today received FDA approval for its ANDA 217461, signaling a strategic entry into the market with implications likely driven by opportunities for generic substitution and c…

FDA QUAGEN Jul 7 — 0.00

FDA Approves Unknown Drug — QUAGEN

QUAGEN has received federal approval for ANDA213892, likely allowing the company to introduce a generic version of the recently approved July 7th product. This expansion of the com…

FDA Milla Jul 6 — 0.00

FDA Approves SODIUM BICARBONATE — Milla Pharmaceuticals Inc.

Milla Pharmaceuticals received FDA approval for its Intravenous Sodium Bicarbonate (ANDA219089) on July 6, 2026, establishing a new generic option for this essential fluid-moving a…

FDA SABA Jul 1 — 0.00

FDA Approves Unknown Drug — SABA ILAC SANAYIVE

SABA ILAC SANAYIVE has secured FDA approval for ANDA 217934, a milestone that is expected to expand the manufacturer's commercial portfolio and provide a solid foundation for futur…

FDA MANKIND Jul 1 — 0.00

FDA Approves Unknown Drug — MANKIND PHARMA

MANKIND PHARMA received FDA approval for its ANDA 220874 on July 1, 2026, according to a notice issued by the regulatory body. This clearance is expected to deliver a significant c…

FDA Macleods Jul 1 — 0.00

FDA Approves CHLORTHALIDONE — Macleods Pharmaceuticals Limited

Macleods Pharmaceuticals Limited and Hikma Pharmaceuticals received FDA approval for their generic chlorthalidone ANDA on July 1, 2026, which is expected to assert significant mark…

FDA ScieGen Jul 1 — 0.00

FDA Approves BRIVARACETAM — ScieGen Pharmaceuticals, Inc.

On July 1, 2026, ScieGen Pharmaceuticals received FDA approval of Brivaracetam (ANDA219952), a generic oral version of the brand-name drug. This approval will likely impact the com…

FDA I3 Jun 30 — 0.00

FDA Approves Unknown Drug — I3 PHARMS

I3 PHARMS announced today the FDA approval of **[Insert Substance Name Here]** under ANDA 219464, signaling a strategic entry into the market with the potential to capitalize on co…

FDA ZYDUS Jun 30 — 0.00

FDA Approves Unknown Drug — ZYDUS PHARMS

Zydus Pharmaceuticals has received FDA approval for a new generic drug, expected to significantly impact the market by providing a cost-effective alternative for patients and compe…

FDA APOTEX Jun 29 — 0.00

FDA Approves Unknown Drug — APOTEX

APOTEX has announced the approval of its ANDA No. 213331 from the FDA, marking the launch of the generic version of the substance and signaling a new competitive entry into the mar…

FDA NOVITIUM Jun 26 — 0.00

FDA Approves Unknown Drug — NOVITIUM PHARMA

Novitium Pharma announced Friday it received FDA approval for its ANDA-219647, as the company moves to expand its generic portfolio with new product launches. This regulatory green…

FDA Viridian Jun 26 — 0.00

FDA Approves LUMVOA — Viridian Therapeutics, Inc.

Viridian Therapeutics announced Tuesday that FDA approval of its intravenous therapy Veligrotug (brand name Lumvoa) has been granted, marking a significant milestone that positions…