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Op-Ed: The FDA’s New Direction Threatens Trump’s Innovation Agenda
23 Oct 2025 15:25 GMT
… FDA) – from fast-tracking lifesaving therapies, approving a record number of generics … . Kennedy Jr. and FDA Commissioner Marty Makary has … disrupted the FDA’s functionality, destabilized … survive into adulthood. The FDA only partially reversed this …
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FDA cites Nephron again for ongoing issues the generics manufacturer has failed to resolve
23 Oct 2025 14:19 GMT
Three years ago, the FDA found so many violations at a Nephron Pharmaceuticals manufacturing facility that the U.S. regulator admitted in a warning letter the issues were so numerous they couldn’t all be documented.
Fast-forward to this year, and the plant …
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Is Your Medication Made in a Contaminated Factory? The FDA Won’t Tell You.
23 Oct 2025 09:09 GMT
… generics, many from India and China.
ProPublica previously disclosed that the FDA … public health, the FDA must protect sensitive … a crucial detail.
Drug companies often have multiple plants, … July, newly named FDA Commissioner Marty Makary promised …
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Opinion: TrumpRx and a most favored nation policy won’t lower prices for patients
24 Oct 2025 10:33 GMT
… the world to receive affordable generics and biosimilars.
Instead of … a rigged system that lets drug companies exploit patents, block competition, … and Purple Book are FDA databases that provide limited … their patents to the FDA and such disclosures should …
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From Idea to Impact: What it really takes to scale healthcare startups in India
26 Oct 2025 01:42 GMT
… from day one, navigating the FDA approval process proved more challenging … years to get our first FDA clearance," Warier admitted. … the West, India has branded generics… for every medicine, we have …
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Biocon, Anthem Biosciences, Onesource Specialty Pharma and Sai Life Sciences Leading BioTech Innovation in India
25 Oct 2025 06:46 GMT
… earn U.S. FDA approval for a biosimilar … spectrum of services spans pharmaceuticals, specialty chemicals, and … It focuses on specialty pharmaceuticals and advanced Active Pharmaceutical … producing high-value, complex generics that bridge important treatment …
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CF buyers club aims to grow access to Vertex's Trikafta through trade-policy workaround
24 Oct 2025 20:12 GMT
… topple access barriers to Vertex Pharmaceuticals’ potentially lifesaving, yet often out … can legally manufacture and export generics of patented drugs, the buyers … ’t been approved by the FDA.
On the other hand, certain …
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mRNA vaccine boosted immune response, life expectancy for cancer patients, UF research finds
24 Oct 2025 15:03 GMT
… into the benefits of repurposing generics, like ivermectin, to fight cancer … head lice and scabies. The FDA has not approved the use …
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Rx Rundown: Alkermes, Takeda, BPD Healthcare and more
24 Oct 2025 12:27 GMT
… billion to acquire Avadel Pharmaceuticals.
Gilead subsidiary Kite … .
BiomX announced new FDA feedback potentially expanding BX004 … for ongoing issues the generics manufacturer has failed … 22.4 million.
Citius Pharmaceuticals announced a registered direct …
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West Pharmaceutical Services, Inc. (NYSE:WST) Q3 2025 Earnings Call Transcript
24 Oct 2025 12:26 GMT
… new GLP-1 molecules and generics. And we expect this market … seals, stoppers and plungers. And generics revenue increased 2.6% organically … number of approvals by the FDA might be a little bit … . There’s an element around generics that were also able to …