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FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA Approves AstraZeneca’s Lupus mAb, Saphnelo

FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.

FDA Launches New Crowdsourcing Challenge for Pediatric Research Questions 

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

Regeneron Receives Expanded Authorized Use from FDA for Antibody COVID-19 Treatment

FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

FDA Approves Interchangeable Biosimilar Insulin

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

FDA’s Pazdur Challenges Attack on Accelerated Approval Program 

Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.

18th Annual CPhI Pharma Awards to Take Place in Milan, Italy

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.

New Drug Approvals on Track at FDA

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

CHMP to Assess Extended Indication of Kineret for COVID-19

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

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