Incyte Corporation reported that the U.S. Food and Drug Administration pushed back the review of the company’s supplemental New Drug Application for Opzelura (ruxolitinib cream) for vitiligo.
In response to the ongoing Russian invasion of Ukraine, Pfizer will cease operations within Russia and proceeds from the company’s subsidiary in that country will be donated to provide direct humanitarian support to the people of Ukraine. Regarding COVID-19, Pfizer Chief Executive Officer Albert Bourla noted in an interview with Face the Nation that it is likely that a fourth booster shot of the company’s vaccine will be needed to fend off another surge of infections.
Pfizer Inc. and Bayer said on March 14 they would maintain humanitarian supply of medicines to Russia, but would pull back from other non-essential spending in the country.
AstraZeneca’s Fasenra (benralizumab) hit a roadblock in attempting to expand the medicine’s indications when the U.S. Food and Drug Administration issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
AstraZeneca and Merck & Co. Inc. announced Lynparza (olaparib) was approved in the United States for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
Biosimilar development continues to advance for the U.S. market in anticipation of becoming an alternative to a brand drug with similar safety and efficacy.
Two months after receiving a gene-edited pig heart, David Bennett Sr. passed away at the age of 57 years.
Shares of bluebird bio fell in trading on March 7 after the company revealed its dire financial straits.
The U.S. Food and Drug Administration approved the expanded use of Bristol Myers Squibb’s cancer drug Opdivo along with chemotherapy as treatment that patients with an aggressive form of lung cancer receive before surgery.
The U.S. Food and Drug Administration turned down Malvern, Pa.-based Ocugen’s Emergency Use Authorization (EUA) request for Covaxin in children ages 2 to 18 years. Covaxin is a Covid-19 vaccine the clinical-stage biopharmaceutical company is co-developing with India’s Bharat Biotech.