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Johnson & Johnson Says FDA Grants Priority Review To Subcutaneous Amivantamab For Recurrent Or Metastatic Head And Neck Cancer, Citing 42% Overall Response Rate In OrigAMI-4 Study
Johnson & Johnson Receives FDA De Novo Authorization For Its OTTAVA Robotic Surgical System
MSN has announced an FDA approval for the drug identified as ANDA209526, a move likely to broaden its product portfolio in the respective therapeutic segment. The approval is expec…
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…
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 Approves Pembrolizumab Or Pembrolizumab And Berahyaluronidase Alfa-pmph Each With Enfortumab Vedotin-ejfv For Muscle Invasive Bladder Cancer
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…
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…
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…
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…
The FDA approved Unknown Drug from ALEMBIC under application ANDA213414 on 2026-06-25.
Mylan Institutional LLC’s June 25, 2026 FDA approval for intravenous ferric carboxymaltose is expected to introduce a generic alternative to the market, potentially reshaping the c…
ScieGen Pharmaceuticals has received FDA approval for its generic version of Tofacitinib Citrate, potentially intensifying price competition in the oral immunosuppressant market. T…
Alembic Pharmaceuticals Limited announced the FDA approval of its ANDA for oseltamivir phosphate oral powder, positioning the company in the market for this essential influenza tre…
The FDA approved Unknown Drug from MICRO LABS under application ANDA217238 on 2026-06-24.
Aurobindo Pharma gained approval for its ANDA208746 on June 24, 2026, introducing a generic version of the brand-name drug icosapent ethyl to the market. This regulatory clearance …
Macleods Pharmaceuticals Limited has received FDA approval for its oral Rifapentine generic, allowing for immediate U.S. market entry. This clearance is poised to boost Macleods' n…
Macleods Pharma announced the list date of its pending ANDA application this week, a development expected to diversify its revenue streams and increase the company's competitive st…
NORWICH announced FDA approval for ANDA217449 on June 17, a strategic regulatory milestone that positions the company for potential generic market entry and revenue diversification…
Annora Pharma received FDA approval for its ANDA 219470 application on June 17, 2026, which is expected to diversify the company's generic portfolio and drive incremental revenue s…