September 2025 – Page 16

FDA Releases Second Batch of Complete Response Letters, Moves to Real-Time Public Disclosure

1 month ago talkbio0Tagged Complete, CRLs, Drug Approval, real-time publishing, regulatory disclosure, Response Letters, United States Food and Drug Administration

FDA; Complete Response Letters; CRLs; real-time publishing; drug approvals; transparency; regulatory disclosure

Enveda Raises $150M Series D, Advances Nature-Inspired Drug Programs

1 month ago talkbio0Tagged Biosciences, Dermatitis, Atopic, Enveda, Immune System Diseases, Investments, Mikael, nature-inspired drug discovery, Series D

Enveda Biosciences; Series D funding; $150 million; nature-inspired drug discovery; atopic dermatitis; immune diseases; Mikael Dolsten; biotech investment

RFK Jr. Faces Bipartisan Senate Criticism After CDC Shakeup

1 month ago talkbio0Tagged bipartisan criticism, Centers for Disease Control and Prevention (U.S.), director firing, Policy, public health medicine (field), RFK Jr., Senate hearing, Shakeup, Trump administration reforms, Vaccines

RFK Jr.; CDC shakeup; bipartisan criticism; Senate hearing; public health; vaccine policy; CDC director firing; Trump administration reforms

Sanofi Phase 3 Eczema Win Falls Short of Analyst Expectations

2 months ago talkbio0Tagged Amlitelimab, Dermatitis, Atopic, Dupixent, EASI-75, Eczema, Expectations, Market, Reaction, sanofi

Sanofi; amlitelimab; phase 3 trial; eczema; atopic dermatitis; analyst expectations; Dupixent; EASI-75; market reaction

AC Immune Narrows Pipeline and Cuts 30% Workforce to Extend Cash Runway

2 months ago talkbio0Tagged Actinium, Alzheimer 's disease, cash runway, Immune, late-stage assets, layoffs, Parkinson Disease, pipeline reduction

AC Immune; pipeline reduction; layoffs; cash runway; biotech; Alzheimer’s disease; Parkinson’s disease; late-stage assets; workforce reduction

AstraZeneca Ends Manufacturing License at Indian Plant and Exits Site as Part of Global Strategy

2 months ago talkbio0Tagged AstraZeneca, Bangalore plant, Contract agreement, Drug Industry, global strategy, India, Manufacturing, manufacturing license, Site of exit

AstraZeneca; India; manufacturing license; site exit; Bangalore plant; contract manufacturing; global strategy; pharmaceutical industry

Endpoints News to Announce 2025 ‘Endpoints 11’ Biotechs to Watch Live in Boston

2 months ago talkbio0Tagged Biopharma, biotech startups, City of Boston, Endpoints, Industry, innovation, live event, trends qualifier

Endpoints 11; biotech startups; biopharma; Boston; live event; industry trends; biotech innovation

FDA Launches New Submission Program for Rare Disease Gene Therapies via CDER and CBER

2 months ago talkbio0Tagged Accelerated, Approved, CBER, CDER, gene therapy, Hereditary Diseases, Infrequent, RDEP, regulatory guidance, submission program, United States Food and Drug Administration

CDER; CBER; rare disease; gene therapy; FDA; submission program; accelerated approval; RDEP; regulatory guidance; rare genetic disorders

Wave RNA Editing Restores Enzyme in Genetic Disorder but Fails to Impress Investors

2 months ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical Trials, enzyme restoration, Investor Reaction, RNA Editing, Wave Life Sciences, WVE-006

Wave Life Sciences; RNA editing; AATD; alpha-1 antitrypsin deficiency; enzyme restoration; clinical trial; investor reaction; WVE-006

Wave Life Sciences Shares Dip After Mixed Data Update on GSK-Partnered AATD Therapy

2 months ago talkbio0Tagged alpha 1-Antitrypsin Deficiency, Clinical Trials, protein levels, RNA Editing, SmithKline Beecham, Wave Life Sciences, WVE-006

Wave Life Sciences; GSK; AATD; RNA editing; WVE-006; clinical trial; protein levels; stock dip; biotech