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FDA Approves ADMA Biologics Increased IVIG Production contractpharma
April 29, 2021
ADMA Biologics, Inc., a commercial biopharmaceutical company dedicated to specialty plasma-derived biologics, received approval from the U.S. FDA for the company’s expanded manufacturing process, enabling fractionation and purification of a ...
FDA Grants Accelerated Approval to Dostarlimab-Gxly for dMMR Endometrial Cancer americanpharmaceuticalreview
April 26, 2021
The Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test ...
Lupin, Sun Pharma, Jubilant Cadista recall generic medicines in US expresspharma
April 26, 2021
Lupin is recalling 17,814 bottles of Cefprozil, Sun Pharma is recalling 13,834 bottles of Riomet and Jubilant Cadista Pharmaceuticals is recalling 12,192 bottles of Itraconazole capsules.
FDA approves GSK’s Jemperli for endometrial cancer pharmaceutical-technology
April 26, 2021
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) programmed death receptor-1 (PD-1) blocking antibody Jemperli (dostarlimab-gxly) based on its Biologics License Application (BLA) for endometrial cancer.
Gland Pharma gets US FDA nod for generic Foscarnet Sodium Injection, Single-Dose Bag for Infusion expresspharma
April 25, 2021
Gland Pharma received approval from the United States Food and Drug Administration (US FDA) for generic Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bag for Infusion.
Zydus Cadila gets final US FDA approval for Propafenone Hydrochloride ER capsules expresspharma
April 25, 2021
Zydus Cadila has received final approval from the USFDA to market Propafenone Hydrochloride Extended-Release Capsules USP, 225 mg, 325 mg, and 425 mg (US RLD: Rythmol Capsules). Propafenone is known as an anti-arrhythmic drug.
Alembic Pharma gets USFDA final approval for Doxepin Hydrochloride Capsules expresspharma
April 25, 2021
Alembic Pharmaceuticals announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg.
Thermo Fisher Scientific’s Amplitude Solution receives FDA authorisation for COVID-19 testing. expresspharma
April 25, 2021
Thermo Fisher Scientific, the world leader in serving science, received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit.
KemPharm Receives $10M Milestone Payment for FDA Approval of AZSTARYS™ americanpharmaceuticalreview
April 23, 2021
KemPharm, Inc. has announced receipt of a regulatory milestone payment of $10 million for the FDA approval of AZSTARYS™ in accordance with the recently amended definitive collaboration and license agreement with Commave Therapeutics, SA, an affiliate ...
FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines prnewswire
April 23, 2021
The U.S. Food and Drug Administration takes its responsibility to ensure medical product quality, safety and effectiveness very seriously.

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