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NewsAlembic Pharma Gains FDA Approval for Generic Ciprodex Otic Suspension in U.S. Market
Alembic Pharma wins FDA ANDA approval for generic Ciprodex Otic Suspension, expanding its U.S. specialty suspension portfolio.
Viatris Gains FDA Approval for RYZUMVI in Presbyopia, Expanding Phentolamine Ophthalmic Indications
Analytik Jena Opens €96M German Facilities to Expand Lab Capacity
FDA Creates CDER Exclusivity Board to Standardize Drug Rulings
Alcon Wins FDA Approval for Brytly Nonprescription Eye Drops
Latest news
11 storiesFDA Warns of Bacterial Contamination in Counterfeit Eye Drops
FDA confirms bacterial contamination in counterfeit eye drops from DLC Laboratories, ProMex, and Laboratorios Sophia found across six U.S. states.
EMA CHMP Recommends Six Medicines for Approval in October 2026
EMA's CHMP issued six positive opinions in October 2026, including oral GLP-1 orforglipron and two biosimilars, with key implications for EU market entry.
Adial Appoints David Rubenstein as Chief Scientist for AT177
Adial Pharmaceuticals names tapinarof architect David Rubenstein as Chief Scientist to lead AT177 through IND-enabling studies toward 2027 first-in-human trials.
Dermata Reports Positive Results from Tome Skincare Study
Dermata Therapeutics reports topline cosmetic study data for Tome Foundational Treatment, with 71% of participants showing improvement after one application.
Oryzon Secures Vafidemstat Patent Allowances in Four Markets
Oryzon secures vafidemstat patent grants in South Korea, Philippines, New Zealand, and Mexico ahead of a Phase III BPD trial.
Zealand Pharma Partners With Generate on $1.2B AI Obesity Deal
Zealand Pharma and Generate Biomedicines partner to use generative AI for novel obesity protein therapeutics, raising early manufacturing and regulatory questions.
Rasonque Gains CHMP Positive Opinion for Pancreatic Cancer
CHMP recommends Rasonque for metastatic pancreatic cancer after a phased review completed in under 150 days, setting a regulatory precedent.
Lonza Completes Its CDMO Transformation After CHI Divestment
Lonza completes its CDMO transformation after divesting Capsules & Health Ingredients, reshaping capacity and pricing for biologics and small molecule clients.
Evotec Appoints Dr. Joanna Holbrook as Chief Scientific Officer
Evotec appoints Dr. Joanna Holbrook as CSO effective November 2026, bringing AI, omics, and translational medicine expertise to its discovery platform.
Enodia Therapeutics Signs Pfizer Deal Worth Over $500 Million
Enodia Therapeutics and Pfizer sign a $500M deal; Pfizer takes full manufacturing and regulatory control post-collaboration.
Insmed Advances Four Phase 3 TPIP Studies
Insmed's PALM program runs four parallel Phase 3 TPIP studies across pulmonary diseases, targeting 2,000+ patients with a once-daily dry powder inhaler.
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Par Health Recalls 22 Lots of Argatroban Injection
FDA Updates Blood Donation Compliance Policy
FDA Launches Rare Disease Framework Initiative
