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New Prescribing Instructions Tighten Use of Controversial Alzheimer's Drug drugs
July 09, 2021
The U.S. Food and Drug Administration on Thursday issued new prescribing rules for the controversial Alzheimer's medication Aduhelm that will likely limit its use.
New Rx Instructions Tighten Use of Controversial Alzheimer Disease Drug drugs
July 09, 2021
The U.S. Food and Drug Administration on Thursday issued new prescribing rules for the controversial Alzheimer disease medication Aduhelm that will likely limit its use.
FDA grants priority review to BLA for AstraZeneca-Amgen’s tezepelumab pharmaceutical-technology
July 09, 2021
The US Food and Drug Administration (FDA) has granted priority review to biologics license application (BLA) for AstraZeneca and Amgen’s experimental drug, tezepelumab, for asthma treatment.
Alembic Pharmaceuticals gets USFDA final approval for Erlotinib Tablets expresspharma
July 09, 2021
Erlotinib Tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer and locally advanced, unresectable or metastatic pancreatic cancer.
Alembic Pharma gets USFDA final nod for Desipramine Hydrochloride Tablets USP expresspharma
July 09, 2021
Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Desipramine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.
Pfizer plans to seek FDA nod for COVID-19 booster next month as Delta spreads firstwordpharma
July 09, 2021
Pfizer's chief scientific officer Mikael Dolsten indicated Thursday that the company plans to seek an FDA emergency-use authorisation next month for a third dose of its COVID-19 vaccine BNT162b2.
FDA declines to approve Provention Bio’s teplizumab for diabetes pharmaceutical-technology
July 08, 2021
The US Food and Drug Administration (FDA) has declined to approve Provention Bio’s biologics licence application (BLA) for teplizumab in type 1 diabetes (T1D), an autoimmune disease.
US Drugmaker Trevena’s Ultra-Strong Painkiller Begins Final-Stage Trials in China firstwordpharma
July 08, 2021
Treneva's TRV-130 has entered Phase III trials in China, as reported Yicai Global on Wednesday.
Novartis shifts Leqvio manufacturing to Austrian facility cphi-online
July 08, 2021
Pharma firm tells FDA tech transfer to its own facility in Schaftenau, Austria is underway after regulator highlighted concerns about third party CDMO site in Italy
Biocytogen/Eucure Biopharma's CTLA-4 and CD40 mAbs Approved for Phase II Clinical Trials by the FDA prnasia
July 07, 2021
Eucure Biopharma announced that the U.S. Food and Drug Administration (FDA) has approved two phase II clinical trials for YH001 (anti-CTLA-4) and YH003 (anti-CD40) in the United States.

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