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Rare-Disease Drug Pasatru Wins FDA Approval; Regeneron Moves Beyond 2020 Trial Halt

The U.S. FDA approved Regeneron’s Pasatru (garetosmab) on August 19 for adults with fibrodysplasia ossificans progressiva, marking a striking turn for a program whose mid-stage study was discontinued in 2020 after dosing was paused following five patient deaths. The approval
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Rare-Disease Drug Pasatru Wins FDA Approval; Regeneron Moves Beyond 2020 Trial Halt

Overton Tapped for FDA; Pharma Watches What Changes Next

U.S. President Donald Trump on August 19 named White House policy aide Heidi Overton to lead the Food and Drug Administration (FDA), months after former Commissioner Marty Makary resigned. Overton, a physician and deputy director of the White House Domestic
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Overton Tapped for FDA; Pharma Watches What Changes Next

FDA Flags “Testing Into Compliance”; Auriga Warning Letter Exposes Quality Unit Failures

Auriga Research Pvt. Ltd. has received an FDA Warning Letter after a February 2026 inspection of its contract testing laboratory in Bengaluru, India. FDA cited significant CGMP violations involving incomplete laboratory records, weak Quality Unit oversight, and OOS investigations based
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FDA Flags “Testing Into Compliance”; Auriga Warning Letter Exposes Quality Unit Failures

No New Clinical Concerns; GMP Issues Still Block Dasynoc’s FDA Review

Xspray Pharma has received another Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Dasynoc. This time, the remaining issues center on GMP observations at third-party manufacturer NerPharMa and additional data from consecutive commercial-scale batches. Xspray still
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No New Clinical Concerns; GMP Issues Still Block Dasynoc’s FDA Review

Gilead, Pfizer and GSK Warn on AI; Fix GMP Workflows Before Scaling

Senior quality leaders from Gilead Sciences, Pfizer and GSK used the Bioprocessing Summit in Boston to caution pharmaceutical companies against rushing weak processes into digital and AI systems. Their message was consistent: digital technology can improve quality operations, but poorly
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Gilead, Pfizer and GSK Warn on AI; Fix GMP Workflows Before Scaling

FDA Warning Letter Flags OOS Averaging; Confirmed OOS Still Led to Batch Release

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to ABS Corporation, a veterinary drug manufacturer in Omaha, Nebraska, after a January 2026 inspection identified significant CGMP violations involving OOS investigations, incoming component testing, and process validation.
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FDA Warning Letter Flags OOS Averaging; Confirmed OOS Still Led to Batch Release

EMA Flags Tavneos Trial Breaches; EU Revokes Approval Over Data Integrity

European regulators have revoked Tavneos’ marketing authorization in the EU and EEA after finding serious problems in how data from its pivotal ADVOCATE study were handled. The EMA concluded that the study could no longer reliably demonstrate efficacy after unblinded
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EMA Flags Tavneos Trial Breaches; EU Revokes Approval Over Data Integrity

27,000 Chemotherapy Vials Recalled; Discoloration Complaints Trigger Nationwide Recall

Shilpa Medicare is voluntarily recalling more than 27,000 vials of Pemetri RTU chemotherapy drug in the United States after market complaints reported green to dark-green discoloration in certain vials. The nationwide action involves two strengths and has been classified by
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27,000 Chemotherapy Vials Recalled; Discoloration Complaints Trigger Nationwide Recall

FDA Panel Votes 9–3 Against Deramiocel; Yet Capricor Pursues a New FDA Path

Capricor Therapeutics plans to amend its BLA for deramiocel after an FDA advisory committee voted 9–3 against finding substantial evidence of effectiveness for Duchenne muscular dystrophy cardiomyopathy. During its August 13 earnings call, the company said the amendment will add
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FDA Panel Votes 9–3 Against Deramiocel; Yet Capricor Pursues a New FDA Path

BioNTech Pushes 25+ Oncology Trials Forward; Validation Readiness Becomes the Commercial Test

BioNTech has appointed Guido Oelkers as its next CEO as the German biotech prepares for a decisive return to oncology. Oelkers will take office by February 1, 2027, at the latest, inheriting falling COVID-19 vaccine sales, a deep cancer pipeline
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BioNTech Pushes 25+ Oncology Trials Forward; Validation Readiness Becomes the Commercial Test