Ultimately, Schniepp's message is clear: a robust quality system is not merely a regulatory obligation, it is a sound business investment. By catching problems early and consistently, companies can ...
Indirect data suggest oral semaglutide outperforms orforglipron on weight loss and tolerability, with patients also favoring its treatment profile.
Orforglipron is the first new molecular entity cleared under the FDA's Commissioner's National Priority Voucher (CNPV) pilot ...
Eli Lilly has agreed to acquire Centessa Pharmaceuticals in a transaction valued at approximately $6.3 billion upfront, with ...
EMA states that reduction in animal testing will be gradual. The first qualification opinion for a NAM used in toxicity ...
The 2023 revision of Annex 1 of the European Union’s good manufacturing practice (GMP) guidelines 1 represents a fundamental shift in expectations for sterile manufacturing. Reg ...
Lilly licenses Insilico's AI drug discovery platform in a deal worth up to $2.75B, signaling a shift in how novel ...
Using patent intelligence data from the FounderNest platform, alongside funding, partnership, and deployment signals across ...
The FDA has approved a high-dose regimen of Biogen’s nusinersen (SPINRAZA) for the treatment of spinal muscular atrophy. 1 ...
During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus ...
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