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President Biden’s Executive Order to Support Biosimilar Drugs Will Provide Lower Cost Options for Patients firstwordpharma
July 12, 2021
The Biosimilars Forum applauds President Biden's directions to the U.S. Department of Health and Human Services "to increase support for generic and biosimilar drugs, which provide low-cost options for patients" .
Pfizer, U.S. health officials to discuss COVID boosters on Monday firstwordpharma
July 12, 2021
Pfizer said Sunday that it will meet with representatives of the FDA as soon as Monday to discuss the need for a booster dose of its COVID-19 vaccine as it prepares to seek authorization, as reported in Investing.com.
FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes fda.gov
July 12, 2021
FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated.
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.

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