FDA
An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
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The company calls the system the first and only “ingestible event marker to transmit digital messages” from inside the body to a receiver without need for direct skin contact.
Over the course of the past year, Novartis has seen significant success with the approval of five drugs that have blockbuster potential and the company sees an additional 25 potential blockbuster drugs in its pipeline.
The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
Previously, Toujeo was approved only for adults aged 18 years and older.
SK Life Science, Inc. Receives US FDA Approval for cenobamate tablets for the Treatment of Partial-Onset Seizures in Adults with Epilepsy
First and only FDA-approved sickle hemoglobin polymerization inhibitor, a new class of therapy
Ted W. Love, president and chief executive officer of GBT, called the approval of Oxbryta a major milestone for the company and for patients with sickle cell disease.
Shares of specialty pharmacy company Aquestive Therapeutics are up more than 18% in premarket trading following a late Friday afternoon approval from the U.S. FDA for Exservan, a treatment for amyotrophic lateral sclerosis.
The latest approval for Calquence, a Bruton tyrosine kinase inhibitor, was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programs.
The approval marks the first time a Korean company independently brought a drug from discovery to FDA approval.