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Pfizer’s investigational antiviral for treating COVID-19 at home at the first onset of symptoms could become available by the end of this year, said the company’s CEO Albert Bourla. Read More
On May 1, revisions will go into effect on the Pharmaceutical Inspection Co-operation Scheme (PICS) Good Manufacturing Principals (GMPs) Guide, addressing the manufacturing of advanced therapy medicinal products (ATMPs) in addition to biological medicinal substances and products. Read More
The FDA’s Oncologic Drugs Advisory Committee met Wednesday for its day two discussion of accelerated approvals for PD-1/L1 inhibitors that haven’t verified their benefit in confirmatory trials, recommending the agency hold off on withdrawing bladder cancer indications for Merck’s Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab). Read More
President Biden in his speech to Congress this week highlighted his support of lower drug prices by proposing to allow Medicare to directly negotiate with drugmakers, echoing language in H.R. 3, which has been reintroduced in the House. Read More
An independent expert panel of the FDA voted 7-2 Tuesday to allow Roche’s Tecentriq (atezolizumab) to remain approved for treating PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) alongside nab-paclitaxel as further trial data are generated. Read More
Merck has issued licenses to five Indian generic drugmakers to produce its COVID-19 antiviral molnupiravir in a move to expand global access to the drug. Read More
Exela Pharma Sciences drew a warning letter from the FDA for inadequate procedures for reporting adverse events and other lapses observed during an agency inspection of its drug outsourcing facility in Lenoir, North Carolina. Read More
The FDA appears to have picked up the pace of inspections after getting off to a slow start in January, issuing significantly more Form 483 inspection reports to manufacturers in March and continuing an upward trend from the previous month. Read More