A failed July inspection of manufacturer Catalent Indiana LLC has delayed another U.S. FDA approval, the latest being that of Scholar Rock Inc.’s selective anti-latent myostatin antibody, apitegromab, ...
Meanwhile, U.S. drug pricing and reimbursement was an issue for 39%, while 32% of respondents to the survey, carried out by the investment bank Lazard, cited FDA regulatory uncertainty. Compared to ...
Heartflow Inc. hasn’t skipped a beat in pumping out good news, with U.S. FDA 510(k) clearance for its next-gen plaque analysis algorithm and platform and Cigna coverage across all lines of coverage ...
The unsettling impact that the Trump administration’s health care and tariff initiatives are having on M&A activity and financing is highlighted in a new survey of CEOs and investors, who say ...
The lack of funding available for early-stage European med-tech and AI-based companies could soon see many go under as their ...
China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in ...
The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, ...
Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other ...
Celltrion Inc. announced plans to acquire from Eli Lilly and Co. a Branchburg, N.J.-based biologics cGMP facility for $330 ...
Mabwell Bioscience Co. Ltd. and Aditum Bio Management Co. LLC announced, in after-market hours Sept. 17, an agreement to ...
Pancreatic cancer remains one of the deadliest cancers, with survival rates showing little improvement over decades and ...
The Royal College of Psychiatrists in the U.K. has published its first-ever guidance to support research into psychedelic ...
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